MalfunctionLHG
ITREL
Received Dec 13, 2001 · Event occurred Jul 24, 2001
Report 6000030-2001-00967 · MDR key 367264
Device
Product problems
- Shock, electrical
- Explanted
- Knotted
- Shielding, inadequate
Patient
46 YR
- Burn(s)
- Other (for use when an appropriate patient code cannot be identified)
- Electric Shock
- Surgical procedure, additional
Narrative
Description of Event or Problem
HCP REPORTED PATIENT EXPERIENCED BURNING AT GENERATOR, SHOCKING & INTERMITTENT STIMULATION SINCE IMPLANT. AT TIME OF EXPLANT IT WAS NOTED THAT THE INSULATION HAD PULLED AWAY FROM LEAD BODY EXPOSING WIRES. THE DEVICE WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW UP REPORT WILL BE SENT WHEN ADDITIONAL INFORMATION IS RECEIVED.