BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3063399 · Received April 17, 2013

    Report

    Report Number
    3004209178-2013-06434
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    March 26, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID: 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37761 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT PLUGGED IN HIS RECHARGER, THE PATIENT WAS "ELECTROCUTED AND THE CORD CAUGHT ON FIRE." IT WAS NOTED THAT THE SYSTEM WAS NOT FUNCTIONAL AND THE CORDS ARE MELTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT WHILE THE PATIENT'S RECHARGER WAS PLUGGED INTO THE WALL THERE WAS SOME SORT OF ELECTRICAL "BLOWOUT" AND THE PATIENT'S RECHARGER CAUGHT FIRE AND THE CORD BLEW ACROSS THE ROOM INTO PIECES. WHEN THE PATIENT TRIED TO RECHARGE, HE RECEIVED SOME SORT OF ELECTRICAL SHOCK WHEN HE DISCONNECTED THE ANTENNA AND PLACED THE RECHARGER OVER THE IMPLANT. IT WAS NOTED THAT THE DEVICE WAS DISPLAYING THE "CALL YOUR DOCTOR" ICON SINCE THE INCIDENT AND AN ANTENNA TEST-TEMP FAILURE CODE WAS ALSO NOTED. FURTHER INFORMATION RECEIVED REPORTED A NEW RECHARGER, ANTENNA AND AC POWER SUPPLY WERE SENT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS CLARIFIED THAT THE RECHARGER IS WHAT SHOCKED THE PATIENT AND HE WAS NOT INJURED. HE WAS ABLE TO CHARGE. HE WAS DOING WELL WITH GREAT COVERAGE AND PAIN RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164554 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR