BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1213283 · Received October 27, 2008

    Report

    Report Number
    3004209178-2008-06894
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED LATE, DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE. IN 2008, THE LEADS AND IMPLANTABLE NEUROSTIMULATOR WERE 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

    THE PATIENT EXPERIENCED A LOSS OF STIMULATION SENSATION. AT A REPROGRAMMING SESSION, ALL ELECTRODE IMPEDANCES WERE GREATER THAN 3600 OHMS. THE DEVICE SYSTEM WAS EXPLANTED. THE PATIENT OUTCOME WAS REPORTED AS 'NO INJURY, RECOVERED WITHOUT SEQUELA'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGEABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3778| IMPLANTED:| PROGRAMMER: MODEL 37742| EXPLANTED:| RECHARGER: MODEL 37752| EXPLANTED:| STIM ACCESSORY: MODEL TITAN ANCHR| IMPLANTED: