BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 1081328 · Received July 24, 2008

    Report

    Report Number
    3004209178-2008-04355
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 27, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANTABLE NEUROSTIMULATOR HAS BEEN 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 IMPLANTABLE NEUROSTIMULATOR (INS) STOPPED WORKING SUDDENLY; THEN IT WOULD WORK WHEN THE PT PRESSED ON IT EXTERNALLY. IMPEDANCES WERE CHECKED AND QUESTION MARKS WOULD APPEAR ON 2 OR MORE OF THE ELECTRODES; IMPEDANCES WERE CHECKED AGAIN APPROX 24 HOURS LATER AND THE QUESTION MARKS WOULD APPEAR ON DIFFERENT ELECTRODES. THE INS WAS REPLACED. THERE WAS NO PATIENT INJURY. THE PT RECOVERED WITHOUT SEQUELA.

    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 53 YR Required Intervention EXTENSION MODEL 7496-51 LOT# YR0014887N| EXPLANTED| IMPLANTED| LEAD MODEL 3986 LOT# NAM004180N| EXPLANTED| IMPLANTED