BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1812641 · Received August 17, 2010

    Report

    Report Number
    3004209178-2010-06187
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 20, 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). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT LOST COVERAGE ON THE RIGHT SIDE. THE LEAD WAS REMOVED AND FOUND TO HAVE BREAKS NEAR THE ELECTRODES. THE LEAD WAS REPLACED AND STIMULATION COVERAGE WAS REGAINED. PATIENT RECOVERED WITHOUT SEQUELA.

    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 44 YR Required Intervention EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA139550N| EXPLANTED:| SLIM ACCESSORY: MODEL 3550-39, LOT# N246305| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE147902N| EXPLANTED:| LEAD: MODEL 3777, LOT# V428070006| IMPLANTED: