MalfunctionIPG
SYNERGY
Received Sep 8, 2004
Report 3004209178-2004-01161 · MDR key 5305668
Device
Product problems
- Electromagnetic Interference
- Shock, electrical
- Electro-magnetic interference (EMI), compatibility/incompatibility
Patient
Not reported
- Discomfort
Narrative
Description of Event or Problem
PARAMEDIC REPORTED PATIENT WAS SHOCKED WHILE GOING THROUGH SECURITY GAST AT "(B)(6) " STORE. PARAMEDIC ATTEMPTED TO TURN OFF PATIENT'S STIMULATOR WITH SYNERGY EZ PATIENT PROGRAMMER. AFTER THE DEVICE WAS OFF, THE PATIENT WAS ASSISTED OUTSIDE. MANUFACTURER RECOMMENDED THE PATIENT FOLLOW UP WITH HCP, LEAVING THE DEVICE OFF UNTIL THEN. PATIENT WAS IMPLANTED 1 WEEK PRIOR TO EVENT. NO REPORT OF DEVICE EXPLANATION. A FOLLOW UP REPORT WILL BE SENT WHEN ADDITIONAL INFORMATION IS RECEIVED.