BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2952463 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00571
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K902002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVALUATION SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE HIGH LEAD IMPEDANCE AND THRESHOLDS MEASUREMENTS IN THE LEFT VENTRICULAR EPICARDIAL LEAD DURING THE IMPLANT PROCEDURE. ATTEMPTS WERE MADE TO RE-MEASURE THE ELECTRICAL MEASUREMENTS, WHICH RESULTED IN THE PHYSICIAN QUESTIONING THE LEAD PERFORMANCE. THE LEAD WAS EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55858 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5071-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR D274TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR