BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1132596 · Received August 22, 2008

    Report

    Report Number
    3004209178-2008-05170
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 25, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT STEPPED IN FRONT OF A PIECE OF MILITARY EQUIPMENT USED TO TRACK INCOMING MORTARS. IT IS ADVISED THAT ALL PERSONS STAY BACK 100-200 METERS. THE PT GOT TOO CLOSE AND IMMEDIATELY FELT A SHARP PAIN AND SHOCKING IN HIS MID BACK AT THE AREA OF PARESTHESIA. AFTER A FEW SECONDS THE IMPLANTABLE NEUROSTIMULATOR SHUT ITSELF OFF. WHEN THE PT LEFT THE FORBIDDEN AREA, HE WAS ABLE TO TURN HIS STIMULATION SYSTEM ON AND OFF. THE PT HAD 2 ACTIVE STIMULATION PROGRAMS. WHEN THE PT TURNED ON THE PROGRAM EMPLOYED AT THE TIME OF THE INITIAL EVENT, THE PT EXPERIENCED SHOCKING AND PAINFUL STIMULATION. THE OTHER PROGRAM WORKED BUT AT HIGHER AMPLITUDE SETTINGS. THE PT FELT NO STIMULATION AT TIMES. IT WAS REPORTED THAT THE DEVICE TURNED ITSELF OFF AND BACK ON WITHOUT WARNING. IT TURNED OFF AFTER APPROX 8 HOURS OF USE. THE OFF PERIODS LASTED UP TO 8 HOURS DURING WHICH THE PT ATTEMPTED TO CHANGE PROGRAMS, INCREASE THE AMPLITUDE UNTIL THE MAXIMUM WAS MET, AND TURN THE DEVICE ON AND OFF, WITHOUT RESULTS. A STUCK KEY ERROR WAS NOTED ON THE PT PROGRAMMER. THE ERROR WAS UNABLE TO BE RESOLVED; DEVICE LOAN/REPAIR WAS CONTACTED. IMPEDANCE VALUES WERE WITHIN THE NORMAL LIMITS. LATERAL AND A/P FILMS REVEALED THAT THE LEAD HAD MIGRATED A FEW CENTIMETERS. THE DEVICE WAS REPROGRAMMED AND THE PT AGAIN RECEIVED THERAPEUTIC BENEFIT AT AMPLITUDES OF 10.5 VOLTS AND 6.5 VOLTS. THE LONGEVITY ESTIMATE OF THE DEVICE WAS 4 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED| LEAD MODEL 3778-75 LOT# V09247012| EXPLANTED| EXPLANTED| EXTENSION MODEL UNK LOT# UNK| EXPLANTED| PROGRAMMER MODEL 37743 LOT# NKE100916N| IMPLANTED| LEAD MODEL 3778 LOT# V081859006| IMPLANTED