BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 2190799 · Received July 28, 2011

    Report

    Report Number
    3004209178-2011-05853
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 1, 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
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECHARGING ISSUES WERE REPORTED. IT WAS NOTED THAT ALL EIGHT COUPLING BOXES WERE ACHIEVED; HOWEVER, THE DEVICE WOULD NOT CHARGE. THE DEVICE HAD 50% CHARGE AND WHEN THE PT SET UP TO RECHARGE, HER DEVICE SHOWED "NO CHARGE." ON (B)(6) 2011 A PHYSICIAN MODE RECHARGE WAS PERFORMED. SINCE THAT TIME, THE NORMAL RECHARGING SCREEN APPEARED, HOWEVER, THE PT COULD NOT GET ANY COUPLING BARS. THE ANTENNA LOCATE FEATURE HAD BEEN ATTEMPTED WITH NO SUCCESS. THE PT ALSO EXPERIENCED ACUTE PAIN AT THE LOCATION OF THE NEUROSTIMULATOR, AND HAD FELT AS IF HER DEVICE HAD MOVED. FLUOROSCOPY AND X-RAYS SHOWED THE DEVICE WAS NOT FLIPPED; HOWEVER, THE LEADS HAD MIGRATED. THE BATTERY WAS DETERMINED TO BE EMPTY (BUT NOT OVERDISCHARGED). THE PT HAD GAINED SOME WEIGHT AND THE DEVICE WAS LOOSE IN THE POCKET. THE RECHARGING DIFFICULTIES WERE ATTRIBUTED TO THE DEVICE MOVING IN THE POCKET. A REVISION WAS PERFORMED ON (B)(6) 2011 DURING WHICH ONE LEAD WAS REMOVED AND NOT REPLACED. IT WAS LATER REPORTED THAT THE PT EXPERIENCED STIMULATION IN THE WRONG LOCATION. THE PT "RECOVERED FINE" AND HAD STIMULATION IN MOST OF HER PAIN AREAS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention PROGRAMMER: MODEL 37743, LOT# NKE160132N| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT# V513037| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB004329V| IMPLANTED:| LEAD: MODEL 3777, LOT# V362289024| IMPLANTED:| LEAD: MODEL 3888, LOT# V513037