BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2160627 · Received July 7, 2011

    Report

    Report Number
    3004209178-2011-05156
    Event Type
    Injury
    Date Received
    July 7, 2011
    Report Date
    April 11, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE NEUROSTIMULATOR FOUND THE DEVICE HAD GONE INTO AN OVER-DISCHARGED STATE FOUR TIMES AND WAS THEREFORE AT AN END-OF-SERVICE STATUS. THE DEVICE WAS RECEIVED WITH NO TELEMETRY AND NO OUTPUT. A PHYSICIAN MODE RECHARGE WAS PERFORMED. THERE WAS GOOD STABLE OUTPUT ON EACH ELECTRODE PAIR AT THE PT'S SETTINGS AND OUTPUT MATCHED PROGRAMMED SETTINGS. THE DEVICE PASSED THE AUTOMATED TEST CONSOLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTED NEUROSTIMULATOR WAS EXPLANTED ON (B)(6) 2011 AND WAS REPLACED WITH A NON-RECHARGEABLE DEVICE. THE PT STATED HE WAS UNABLE TO KEEP UP WITH RECHARGING HIS NEUROSTIMULATOR AND THEREFORE REQUESTED THE DEVICE BE REPLACED WITH A NON-RECHARGEABLE DEVICE. THE DEVICE WAS INTERROGATED BEFORE EXPLANT AND SHOWED THE NEUROSTIMULATOR WAS OVER-DISCHARGED. COMMUNICATION AND COUPLING ISSUES HAD PREVIOUSLY BEEN REPORTED AND WERE BELIEVED TO BE DUE TO OVER-DISCHARGE. AFTER REPLACEMENT, THE PT WAS RECEIVING GOOD STIMULATION COVERAGE AND RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE119842N| LEAD: MODEL 3778, LOT# V185702002| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB052968V| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB053596V| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA125831N| EXPLANTED:| LEAD: MODEL 3778, LOT# V192698002| IMPLANTED: