BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1060643 · Received June 13, 2008

    Report

    Report Number
    3004209178-2008-03199
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 29, 2008
    Report Date
    May 14, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: EXTENSION. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS ON 06/03/2008 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 PT EXPERIENCED A SUDDEN LOSS OF STIMULATION AND WAS UNABLE TO USE HIS NEUROSTIMULATION SYSTEM. HE WAS SEEN FOR REPROGRAMMING AND ALL IMPEDANCES WERE GREATER THAN 3600 OHMS. THE HCP DETERMINED THE EXTENSION WAS FRACTURED. THE EXTENSION WAS REPLACED AND IMPEDANCES WERE GOOD. THE STIMULATION WAS GOOD AT ORIGINAL SETTINGS. THE PT OUTCOME WAS REPORTED AS 'NO INJURY, RECOVERED WITHOUT SEQUELA'.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention EXTENSION MODEL# 3708240| IMPLANTED| LEAD MODEL 3487A LOT# V055387IMPLANTED| EXPLANTED| LEAD MODEL 3487A LOT# V055387 IMPLANTED| EXPLANTED| EXPLANTED| PROGRAMMER MODEL 37742 LOT# NJD052872N| RECHARGER MODEL 37752 LOT# NKA030614N