Medtronic SynchroMed II Programmable Pump, model 8637-40. The contents of the inner package have been sterilized by ethy

FDA device recall Z-1151-2008 · posted 2008-03-22 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

LKK

Quantity affected

~102,792 worldwide. 90,330 within US and 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, De

Date initiated

2008-01-16

Date posted

2008-03-22

Date terminated

2011-06-06

Location

Minneapolis, MN