MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM

K965251 · Medtronic Vascular · MAJ · Mar 18, 1997 · Anesthesiology

Device Facts

• Record ID: K965251
• Device Name: MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM
• Applicant: Medtronic Vascular
• Product Code: MAJ · Anesthesiology
• Decision Date: Mar 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5120
• Device Class: Class 2
• Attributes: Therapeutic

Device Story

The AlgoLine Intraspinal Catheter System is an implantable device designed for the delivery of medication into the intraspinal space. It functions as a conduit for continuous infusion of narcotics or other therapeutic agents to manage pain. The system is implanted by a physician in a clinical or surgical setting. It consists of a catheter that is placed into the subarachnoid or epidural space. The device facilitates long-term drug administration, potentially benefiting patients with intractable or refractory pain, such as those with cancer. Healthcare providers monitor the system for performance, ensuring proper drug delivery and checking for complications like occlusion, leakage, or migration. The device is intended to provide a stable pathway for medication, thereby supporting pain management protocols.

Clinical Evidence

No clinical data provided. The document contains a bibliography of literature regarding intraspinal catheterization and a summary of product complaint history (12 catheters involved in 9 complaints out of 5,000 distributed).

Technological Characteristics

Implantable intraspinal catheter system. Components include catheters and associated accessories (e.g., Tuohy needles). Mechanical device; no electronic or software components described.

Regulatory Classification

Identification

An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.

Reference Devices

• Brant JM. Seminars in Oncology Nursing 11:203-212, 1995
• Chabal C et al. The Pain Clinic 3:19-23, 1989
• de Champs C et al. Infection 19:181-183, 1991
• Crul BJ and EM Delhaas. Reg Anesth 16:209-213, 1991
• DuPen SL et al. Cancer 59:986-993, 1987
• DuPen SL et al. Anesthesiology 73:906-909, 1990
• Krames ES. Journal of Pain and Symptom Management 8:36-46, 1993
• Lamer TJ. Mayo Clin Proc 69:473-480, 1994
• Lubenow TR and AD Ivankovich. Seminars in Surgical Oncology 6:173-176, 1990
• Mercadante S. Journal of Pain and Symptom Management 9:201-207, 1994
• Nitescu P et al. The Clinical Journal of Pain 11:45-62, 1995
• Nitescu P et al. The Clinical Journal of Pain 7:143-161, 1991
• Sjoberg M et al. Anesthesiology 80:284-297, 1994
• Stamer U and C Maier. Anaesthesist 41:288-296, 1992
• Wagemans MFM et al. Ned Tijdschr Geneeskd 137:1553-1557, 1993
• Waldman SE et al. International Anesthesia Research Society, 1986

Submission Summary (Full Text)

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Mar. 14. 1997 6:03PM MEDTRONIC NEURO MKTG 612 5725694 No. 9620 P. 4

MAR 18 1997

K 965251; Medtronic PS Medical AlgoLine Intraspinal Catheter System

SUMMARY OF SAFETY AND EFFECTIVENESS PROBLEMS ASSOCIATED WITH INTRASPINAL CATHETERS (ADVERSE EFFECTS)

The adverse effects associated with the use of the AlgoLine Intraspinal Catheter System may include, but may not be limited to, the following.

Catheter Complications

Change in catheter performance, due to kinking, disconnection, leakage, breakage, complete or partial occlusion, dislodgement or migration, or fibrosis or hygroma, which can result in:

- delivery of drug into the subcutaneous tissue,
- drug withdrawal symptoms,
- return of underlying symptoms,
- free-floating catheter in the cerebrospinal fluid (CSF),
- underinfusion of the drug,
- CSF leak leading to spinal headache, CSF subcutaneous collection, or rare CNS pressure-related problems,
- damage to the spinal cord, or
- surgical replacement / revision of the catheter.

Drug Complications

- Local and systemic drug toxicity and related side effects
- Complications due to use of untested drugs with the system
- Complications due to using drugs not in accordance with the drug labeling

Procedural (Surgical) Complications

- Lumbar puncture-type headache
- CSF leak leading to spinal headache, CSF subcutaneous collection, or rare CNS pressure-related problems
- Radiculitis
- Arachnoiditis
- Bleeding
- Damage to the spinal cord
- Meningitis
- Spinal headache
- Medical complications
- Complications from anesthesia
- Damage to the catheter due to improper handling

Other

- Allergic or immune system response to the implanted materials
- Body rejection phenomena
- Complications due to the interaction of the catheter with unusual physiological variations in patients
- Surgical replacement of the catheter due to complications
- Complications due to other intervening acts

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# PRODUCT COMPLAINT HISTORY

Approximately 5,000 AlgoLine intraspinal catheters of various models and designs have been distributed worldwide. As of January 15, 1997, the complaint history consists of a total of nine complaints involving 12 catheters reported. These complaints have included:

- (3 ea) Catheter fracture
- (3 ea) Catheter leakage
- (2 ea) Strain relief missing from package (involving 5 packages)
- (1 ea) Tuohy needle broke during use

## BIBLIOGRAPHY

1. Brant JM. The use of access devices in cancer pain control. Seminars in Oncology Nursing 11:203-212, 1995.
2. Chabal C, RP Buckley, L Jacobson, L Butler and T Murphy. Long term epidural morphine in the treatment of cancer pain. The Pain Clinic 3:19-23, 1989.
3. de Champs C, D Guelon, D Joyon, D Sirot, M Chanal and J Sirot. Treatment of a meningitis due to an Enterobacter aerogenes producing a derepressed cephalosporinase and a Klebsiella pneumoniae producing an extended-spectrum β-lactamase. Infection (Germany) 19:181-183, 1991.
4. Crul BJ and EM Delhaas. Technical complications during long-term subarachnoid or epidural administration of morphine in terminally ill cancer patients: a review of 140 cases. Reg Anesth 16:209-213, 1991.
5. DuPen SL, DG Peterson, AJ Bogosian, DH Ramsey, C Larson-and-M Omoto. A new permanent exteriorized epidural catheter for narcotic self-administration to control cancer pain. Cancer 59:986-993, 1987.
6. DuPen SL, DG Peterson, A Williams, DH Ramsey, and AJ Bogosian. Infection during chronic epidural catheterization: diagnosis and treatment. Anesthesiology 73:906-909, 1990
7. Krames ES. Intrathecal infusional therapies for intractable pain: patient management guidelines. Journal of Pain and Symptom Management 8:36-46, 1993.
8. Lamer TJ. Treatment of cancer-related pain: when orally administered medications fail. Mayo Clin Proc 69:473-480, 1994.
9. Lubenow TR and AD Ivankovich. Intraspinal narcotics for treatment of cancer pain. Seminars in Surgical Oncology 6:173-176, 1990.
10. Mercadante S. Intrathecal morphine and bupivacaine in advanced cancer pain patients implanted at home. Journal of Pain and Symptom Management 9:201-207, 1994.

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11. Nitescu P, M Sjoberg, L Appelgren and I Curelaru. Complications of intrathecal opioids and bupivacaine in the treatment of "refractory" cancer pain. The Clinical Journal of Pain 11:45-62, 1995.

12. Nitescu P, L Appelgren, E Hultman, L-E Linder, M Sjoberg and I Curelaru. Long-term, open catheterization of the spinal subarachnoid space for continuous infusion of narcotic and bupivacaine in patients with "refractory" cancer pain. The Clinical Journal of Pain 7:143-161, 1991.

13. Sjoberg M, P Nitescu, L Appelgren and I Curelaru. Long-term intrathecal morphine and bupivacaine in patients with refractory cancer pain. Anesthesiology 80:284-297, 1994.

14. Stamer U and C Maier. Epidural opiates: cancer pain management in outpatients. (Abstract) Anaesthesist 41:288-296, 1992.

15. Wagemans MFM, EM Spoelder, WWA Zuurmond and JJ De Lange. Continuous intrathecal analgesia in terminal cancer patients within transmural health care. Ned Tijdschr Geneeskd (Netherlands) 137:1553-1557, 1993.

16. Waldman SE, GS Feldstein, ML Allen and G Turnage. Selection of patients for implantable intraspinal narcotic deliver systems. International Anesthesia Research Society. 1986.