BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1971021 · Received January 6, 2011

    Report

    Report Number
    3004209178-2011-00105
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    September 1, 2010
    Report Date
    December 21, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S NEUROSTIMULATOR WAS IN A SUSPECTED OVERDISCHARGE CONDITION WITH THE CLINICIAN PROGRAMMER UNABLE TO COMMUNICATE WITH THE DEVICE. THE PT HAD NOT USED THE STIMULATION OR RECHARGED IN 6 TO 8 MONTHS. A PHYSICIAN MODE RECHARGE (PMR) WAS PERFORMED IN (B)(6) 2010, AND WAS ABLE TO RECHARGE. APPROX ONE MONTH LATER, THE DEVICE WAS AGAIN IN AN OVERDISCHARGE CONDITION (NO TELEMETRY POSSIBLE WITH CLINICIAN PROGRAMMER) AND ANOTHER PMR WAS PERFORMED BUT WAS SUBSEQUENTLY UNABLE TO CHARGE THE DEVICE OR HOLD A CHARGE AFTER 5 HOURS OF RECHARGING. THERE WERE 8 COUPLING BARS SHADED DURING THE RECHARGING. THE OVERDISCHARGE CONDITION OF THE DEVICE WAS UNABLE TO BE RESOLVED AND THE PT WAS SCHEDULED TO HAVE THEIR DEVICE REPLACED. IF ADD'L INFO IS RECEIVED, A F/U REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGEABLE NEUROSTIMULATOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR EXPLANTED:| LEAD: MODEL 3777, LOT# N0037138| IMPLANTED:| LEAD: MODEL 3777, LOT# N0029999| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA012480N| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD015214N