BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2093957 · Received May 16, 2011

    Report

    Report Number
    3004209178-2011-03571
    Event Type
    Injury
    Date Received
    May 16, 2011
    Report Date
    April 18, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION IN WHICH HER RECHARGEABLE DEVICE WAS CHANGED TO A NON RECHARGEABLE DEVICE. THE PATIENT ALSO RECEIVED A NEW "WIRE". ADDITIONAL INFORMATION WAS REQUESTED.

    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 Required Intervention ACCESSORY: MODEL 37752, LOT# NKA036589N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB016597V| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB016598V| IMPLANTED:| LEAD: MODEL 3778, LOT# V007368| PROGRAMMER: MODEL 37743, LOT# NKE101787N| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V116594019