BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTAD STANDARD LEAD 1X8

    MDR report key: 2013494 · Received February 3, 2011

    Report

    Report Number
    6000153-2011-00864
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    Manufacturer
    MPROC, VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO THE IMPLANTING PHYSICIAN HAD DIFFICULTY INSERTING THE STYLETS INTO THE LEADS. NEITHER ONE OF THE TWO GREEN STYLETS COULD BE INSERTED INTO THE LEAD. HE TRIED TO INSERT THE WHITE STYLET, BUT IT ALSO WOULD NOT GO INTO THE LEAD. IMMEDIATELY AFTER PASSING THE PROXIMAL CONNECTOR PINS, THE STYLET WOULD GET STUCK IN THE LEAD. GREEN STYLETS WOULD NOT GO INTO THE LEAD AT ALL. THE PHYSICIAN TRIED TO WET THE STYLET PHYSIOLOGIC SOLUTION TO MAKE IT SLIDE BETTER, BUT THE PROBLEM PERSISTED. AFTER TRYING FOR OVER AN HOUR THE PHYSICIAN OPENED A NEW OCTAPOLAR LEAD AND COMPLETED THE IMPLANT SUCCESSFULLY. PT IS DOING WELL AND NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTAD STANDARD LEAD 1X8 LGW MPROC, VILLALBA 3877 V10159394

    Patients

    Seq Age Sex Outcome Treatment
    1