BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1244776 · Received November 20, 2008

    Report

    Report Number
    3004209178-2008-07613
    Event Type
    Malfunction
    Date Received
    November 20, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    HIGH IMPEDANCES WERE MEASURED ON ONE ELECTRODE OF A QUADRIPOLAR LEAD. THE OTHER THREE ELECTRODES HAD IMPEDANCES AROUND 800-900 OHMS. THE HCP HAD USED A FORCEP TO TIGHTEN DURING THE PROCEDURE. PT SYMPTOMS AND OUTCOME WERE NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 LEAD: MODEL UNK| EXPLANTED:| IMPLANTED: