BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1230640 · Received November 6, 2008

    Report

    Report Number
    3004209178-2008-07287
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 13, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED NO STIMULATION SENSATION. THE PT SPOKE WITH THE MFR REP. THE PT WANTED THE DEVICE REMOVED BECAUSE "IT DID NOT WORK". THE PT WAS DIFFICULT TO UNDERSTAND. THE PT WAS REDIRECTED TO CONTACT THE PHYSICIAN. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 52 YR EXPLANTED:| LEAD: MODEL 3776| LEAD: MODEL 3776| PROGRAMMER: MODEL 37742| ACCESSORY: MODEL 37752| EXPLANTED: