BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1902248 · Received November 15, 2010

    Report

    Report Number
    3004209178-2010-09490
    Event Type
    Injury
    Date Received
    November 15, 2010
    Date of Event
    October 1, 2009
    Report Date
    November 1, 2010
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS NOT TAKING A CHARGE. A DEVICE OVERDISCHARGE WAS SUSPECTED. PT COMPLIANCE WAS PRIMARY REASON FOR OVERDISCHARGE. THE PT STATED SHE LAST FELT STIMULATION IN (B)(6) 2009. THE PT INDICATED SHE HAD NOT RECHARGED HER IMPLANT IN OVER A MONTH. ON (B)(6) 2010, IT WAS REPORTED SINCE PT'S OVERDISCHARGE, SHE WAS HAVING TO RECHARGE EVERY 2 DAYS, COMPARED TO THE SAME LEVEL OF USAGE AS BEFORE, BUT ONLY RECHARGED ONCE A MONTH. THE PT ONLY USED HALF THE BATTERY IN THAT MONTH PERIOD. THE PT HAD STIMULATION ON ALL DAY AT AROUND 5.4 AMPLITUDE. ON (B)(6) 2010, HCP INDICATED PT HAD A REVISION DONE ON (B)(6).

    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 43 YR Required Intervention EXPLANTED:| PROGRAMMER: MODEL 37742, LOT #NJD037849N| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT #NKA025651N| EXTENSION: MODEL 37083, LOT # NKC010005N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT #J0343674V| IMPLANTED:| EXPLANTED:| IMPLANTED: