BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 2083016 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-03251
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE STIMULATOR WAS "SIDEWAYS" AND THERE WAS A LOW BATTERY MESSAGE ON THE STIMULATOR. THE STIMULATOR POCKET WAS REVISED AND THE PT WAS "FINE." THE PT COULD CHARGE WITH MAXIMUM EFFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention ACCESSORY: MODEL 37752, LOT# NKA142489N| LEAD: MODEL 39565-65, LOT# V492952035| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE150372N| IMPLANTED: