Medtronic, Model 8870, Application Software Card is part of the SynchroMed II Drug Infusion System. The System includes

FDA device recall Z-1338-2012 · posted 2012-03-30 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

Medtronic has confirmed that an algorithm used in the Model 8870 application card software has resulted in nine (9) occurrences of an incorrectly displayed Schedule to replace the pump by date. It is estimated that there are more than 140,000 SynchroMed II pump implants worldwide. A patient with a pump reaching EOS prior to replacement may experience the return of underlying symptoms and/or wit

Action taken

Medtronic mailed an "Urgent Medical Device Correction " letter addressed to Dear Healthcare Professional on March 12, 2012. The letter described the problem, Background, Clinical Manifestations, Recommendations, and Additional Information. To ensure there is no interruption in therapy, pump replacements should be scheduled before the ERI alarm sounds and the pump reaches its 7-year end of service. Customers were advised to forward the Urgent Medical Device Correction letter to patients whose name appears on their Pump Replacement List. Reimbursement SupportFor assistance with prior authorization, contact Medtronic Reimbursement at the numbers below: Therapy for Severe Spasticity: (800) 292-2903 Pain Therapies: (866) 962-9909 For questions regarding the letter call 800-328-0810.

Root cause

Software design

Status

Terminated

Product code

LKK

Quantity affected

6338

Distribution

Nationwide Distribution

Date initiated

2012-03-12

Date posted

2012-03-30

Date terminated

2016-04-29

Location

Minneapolis, MN