BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1830804 · Received September 8, 2010

    Report

    Report Number
    3004209178-2010-06858
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 14, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD THEIR DEVICE REMOVED BECAUSE OF NORMAL BATTERY DEPLETION. IT WAS NOTED THAT THE PT ALSO HAD AN INFECTION (NOT SPECIFIED). THE PT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention STIM ACCESSORY: MODEL 3550-39, LOT# UNK| STIM ACCESSORY: MODEL 3550-39, LOT# UNK| EXTENSION: MODEL 37081, LOT# NJB056251V| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB057563V| EXPLANTED: