BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1173723 · Received September 17, 2008

    Report

    Report Number
    3004209178-2008-05850
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    March 1, 2006
    Report Date
    August 18, 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
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INTERMITTENT STIMULATION.

    Description of Event or Problem · 1

    IN 2006, THE PATIENT REPORTED HER DOCTOR TOLD HER THE WIRES WERE BROKEN, BUT THE DOCTOR WAS NOT WILLING TO FIX THEM. THE PATIENT EXPERIENCED INTERMITTENT STIMULATION. THE PATIENT REQUESTED A LISTING OF OTHER PHYSICIANS. THIS EVENT WAS RE-EVALUATED FOR REPORTABILITY AFTER THE FILE WAS RE-OPENED BECAUSE THE STIMULATOR WAS RETURNED FOR DISPOSAL. ADDITIONAL INFORMATION 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 ITREL 3 LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other EXPLANTED:| LEAD: MODEL 3487A| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7434| EXTENSION: MODEL 7495| IMPLANTED: