BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1994346 · Received January 14, 2011

    Report

    Report Number
    3004209178-2011-00401
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Report Date
    January 5, 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE COUPLING AND/OR COMMUNICATION ISSUES. THE ANTENNA LOCATE FEATURE WAS TRIED AND THE SCALE WAS IN THE 50 RANGE. THE PATIENT HAD EXPERIENCED COUPLING ISSUES SINCE IMPLANT; THE PATIENT COULD NOT OBTAIN MORE THAN TWO BARS. PALPATION OF THE STIMULATOR POCKET NOT THE DEVICE APPEARED TO BE VERY SUPERFICIAL TO THE SKIN. A SECOND RECHARGER ALSO COULD NOT MAINTAIN GOOD COUPLING. X-RAY WAS PERFORMED AND STIMULATOR DID NOT APPEAR TO BE FLIPPED. THERAPY WAS WORKING WELL OUTSIDE OF COUPLING ISSUES. THE STIMULATOR WAS IMPLANTED IN THE PATIENT'S FLANK AREA. THE PATIENT SCHEDULED FOR A POCKET REVISION AND/OR BATTERY REPLACEMENT TO TAKE PLACE ON (B)(6) 2011. THE PHYSICIAN NOTED THAT THE DEVICE WAS IMPLANTED 1 CM OR LESS BELOW THE SKIN AND WASN'T FLIPPED, SO IT "MUST BE A BAD BATTERY". ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB001001V| LEAD: MODEL 3998, LOT# V436664