BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1893093 · Received November 2, 2010

    Report

    Report Number
    3004209178-2010-08731
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 7, 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 DEVICE WAS UNRESPONSIVE TO TELEMETRY ATTEMPTS USING THE PHYSICIAN PROGRAMMER, THE PT PROGRAMMER, AND THE RECHARGER. THIS BEGAN IMMEDIATELY FOLLOWING A NUCLEAR MIGB SCAN PERFORMED ON THE PT. IT WAS NOTED THAT THE PT'S INS WAS FULLY CHARGED BEFORE THE SCAN WAS PERFORMED. FOLLOW THE LACK OF RESPONSIVENESS OF INS, A PHYSICIAN MODE RECHARGE (PMR) WAS INITIATED. THE PMR WAS THEN DISCONTINUED AND AN AL WAS INITIATED. THE INS RECHARGER WAS INTERROGATED AND PRODUCED A POWER ON RESET (POR) MESSAGE. A REGULAR RECHARGE SCREEN WAS THEN DISPLAYED INDICATING A LOW BATTERY. NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED. ADD'L INFO WAS PROVIDED AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    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 36 YR IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA110910N| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# V073560038| PROGRAMMER: MODEL 37743, LOT# NKE100287N| IMPLANTED: