BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2013504 · Received February 3, 2011

    Report

    Report Number
    3004209178-2011-00849
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 19, 2011
    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

    THE PT STOOD TOO CLOSELY TO A BURN PILE. SHE BELIEVED HER IMPLANTABLE NEUROSTIMULATOR GOT TOO HOT AND AFTERWARD DIDN'T HOLD A BATTERY CHARGE AS LONG. THE PT HAD NO DISCOMFORT AT THE SITE. THE PT USED THERAPY NEARLY 24 HOURS A DAY. THE PT WAS SEEN BY A FIELD REP. THE NEUROSTIMULATOR CHARGING LOGS WERE REVIEWED. IT NEEDED TO BE RECHARGED EVERY 2 WEEKS WHICH SEEMED CONSISTENT WITH THE PRIOR INTERVAL. INTERROGATION REVEALED HIGH OUT-OF-RANGE BIPOLAR IMPEDANCES INVOLVING ELECTRODES 3, 14, AND 15. THE FIELD REPRESENTATIVE REPROGRAMMED THE DEVICE TO EXCLUDE THE AFFECTED ELECTRODES FROM PROGRAMS 1 AND 2. SHE WAS GETTING GOOD STIMULATION. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL 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 37 YR EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT# V160205| PROGRAMMER: MODEL 37743, LOT# NKE129515N| EXPLANTED:| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA131062N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB002469V| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB015938N| EXPLANTED:| LEAD: MODEL 3888, LOT# V273726| LEAD: MODEL 3487A, LOT# V284057| EXPLANTED:| LEAD: MODEL 3487A, LOT# V284057| IMPLANTED: