BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1812482 · Received August 16, 2010

    Report

    Report Number
    3004209178-2010-06159
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS UNABLE TO CHARGE THEIR DEVICE. IT WAS UNK WHETHER THE DEVICE FLIPPED WITHIN PT, SO THE PHYSICIAN REPLACED THE DEVICE. PT'S STATUS UNK. ADDITIONAL INFO HAS BEEN REQUESTED AND WILL BE MADE AS FOLLOW-UP AS IT 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 78 YR Female Required Intervention ACCESSORY: MODEL 37752, LOT # NKA111292N| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT # NJB029776V| EXTENSION: MODEL 37081, LOT # NJB034745V| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED: | LEAD: MODEL 3778, LOT # V105804025| LEAD: MODEL 3778, LOT # V105804026| PROGRAMMER: MODEL 37743, LOT # NKE101706N| IMPLANTED:| EXPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT # NKA111292N| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT # NJB034745V| EXPLANTED:| LEAD: MODEL 3778, LOT # V105804026| IMPLANTED:| LEAD: MODEL 3778, LOT # V105804025| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE101706N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT # NJB029776V