BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1071285 · Received July 8, 2008

    Report

    Report Number
    3004209178-2008-03816
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    April 1, 2008
    Report Date
    June 11, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WHEN THE PT'S CAMPING TRAILER WAS PLUGGED INTO AN ELECTRICAL OUTLET, THE PT EXPERIENCED A SHOCKING SENSATION WHENEVER HE TOUCHED THE METAL OF THE CAMPER WITH HIS STIMULATOR TURNED ON; HE DID NOT FEEL IT WHEN THE STIMULATOR WAS TURNED OFF. WHEN THE CAMPER WAS PLUGGED INTO A DIFFERENT OUTLET, IT STOPPED. HE DID RECEIVE SOME SMALL SHOCKS ON OCCASION WHEN HE TOUCHED DIFFERENT ELECTRICAL ITEMS; THE PT THOUGHT IT MUST BE WHEN SOMETHING WASN'T GROUNDED PROPERLY. HE SPOKE TO A CONTRACTOR WHO STATED MOST PEOPLE WOULDN'T HAVE FELT THE SHOCK; THE PT STATED THAT HE MUST BE MORE SENSITIVE NOW. NO ONE ELSE FELT THE SHOCKING SENSATION UNTIL THE PT TOUCHED THEM WHILE THEY WERE TOUCHING THE CAMPER. USING A VOLTAGE METER GROUNDED ON ONE SIDE AND THE OTHER IN HIS HAND (WHILE TOUCHING CAMPER) HE HAD A READING TOPPING OUT AT 17 VOLTS. THE PT'S STIMULATOR WAS LOCATED IN HIS BACK. THE PT WAS AT HOME. HIS STATUS WAS "GOOD". THE PT WAS ENCOURAGED TO CONTACT HIS HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTENSION MODEL 37082 LOT# NKB011382N| EXPLANTED| IMPLANTED| IMPLANTED| LEAD MODEL LEAD LOT# UNK| RECHARGER MODEL 37752| PROGRAMMER MODEL 37742 LOT# NJD057251N| EXPLANTED