Recall Z-1154-2008 · LKK Pump, Infusion, Implanted, Programmable

Medtronic Neuromodulation

Medtronic IsoMed Implantable Constant-Flow Infusion Pump, model 8472-60. The contents of the inner package have been sterilized by ethylene oxide gas. Reservoir size: 60 mL. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. The implantable Medtronic IsoMed Constant-Flow Infusion Pump is part of the IsoMed Constant-Flow Infusion System designed to contain and admini

Date	Mar 22, 2008 (initiated Jan 16, 2008)
Status	Terminated
Reason	Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. On January 16, 2008, Medtronic sent a letter to doctors who implant these d
Root cause	Device Design
Action	An Urgent Medial Device Correction letter was sent January 16, 2008, to Health Care Professionals. The letter describes the incidences, symptoms and recommendations for patient management. Excerpts from the approved Medtronic Professional Labeling are also included with the letter. The firm has requested unreported inflammatory mass in a patient with a Medtroinc device to the firm and to the FDA MedWatch Program by phone at 1-800-FDA-1088. Additional assistance may be obtained by contacting Medtronic Neuromodulation Technical Services at 1-800-707-0933.
Quantity	102,792 worldwide. 90,330 within US, 12,462 OUS
Distribution	Worldwide Distribution -- USA including states of Washington D.C., Puerto Rico, and countries of Aruba, Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Faroe Islands, Finland, France, French Polynesia, Germany, Greece,
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.