MalfunctionLLK

SYNCHROMED EL

Received Feb 22, 2007 · Event occurred Jan 23, 2006

Report 6000030-2007-00644 · MDR key 839785

Device

Generic name

Llk

Manufacturer

Rice Creek Manufacturing

Model number

8627

Catalog number

Lot number

Product problems

Explanted

Patient

56 YR

Surgical procedure

Narrative

Additional Manufacturer Narrative

FINAL DEVICE ANALYSIS REVEALS: MOTOR SHAFT GEAR WEAR.

Description of Event or Problem

MEDTRONIC RECEIVED RETURNED PRODUCT FOR ANALYSIS AND DISPOSAL AFTER AN IMPLANT DURATION OF 75 MONTHS. THE INFUSION PUMP WAS PROGRAMMED TO INFUSE BUPIVICAINE 40MG/ML AT 1.842MG/DAY.