Medtronic DBS" 3387 Lead Kit for Deep brain stimulation, DBS Leads: Proximal 40 mm, Distal 12.0 mm, Medtronic, Inc. Medt

FDA device recall Z-0186-2009 · posted 2008-10-27 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

Medtronic has received reports of DBS" leads being damaged at the proximal connector end of the lead when the lead cap is used in the implant procedure. The lead damage is the result of excessive torsion and / or tensile lading of the proximal connector end of the lead. Data also suggest that excessive torque while tightening or loosening the setscrews may twist the setscrew connector block and d

Action taken

Consignees were sent a "Medtronic Urgent: Medical Device Correction" letter 8/2008. The letter addressed to Healthcare Professionals, described the product involved, explanation of the issue, recommendations for Implant and included an attachment "Updated Instructions for Using the Lead Cap". Contact Medtronic Neuromodulation at 1-800-707-0933 for assistance.

Root cause

Process design

Status

Terminated

Product code

MHY

Quantity affected

3939

Distribution

AL, AZ, AR, CA, CO, CT, FL, DC, GA, HI, ID, IL , IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE , NV, NH, NJ, NM, NY, NC, ND, OH, OR, OK, PA, RI, SC, SD, TN, TX, UT , VT, VA, WA, WV, and WI. A

Date initiated

2008-06-14

Date posted

2008-10-27

Date terminated

2011-12-31

Location

Minneapolis, MN