inforMED
MalfunctionIPG

SYNERGY

Received Sep 8, 2004

Report 3004209178-2004-01161 · MDR key 5305668

Device

Model number

7427

Catalog number

NA

Lot number

NA

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.