BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW-IN

    MDR report key: 2943926 · Received February 5, 2013

    Report

    Report Number
    2649622-2013-00069
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K031274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT ATRIAL (RA) EPICARDIAL PACING LEAD EXPERIENCED LOW IMPEDANCE, WAS OVERSENSING FAR FIELD R WAVES (FFRW) AND UNDERSENSING P WAVES. THE RIGHT VENTRICULAR (RV) EPICARDIAL PACING LEAD HAD HIGH PACING THRESHOLDS. THE RA AND RV LEADS WERE CAPPED AND REPLACED. DURING THE PROCEDURE, THE REPLACEMENT EPICARDIAL LEAD'S TIP WAS UNABLE TO BE SEATED INTO THE APPLICATOR PRIOR TO THE LEAD'S IMPLANT. THE LEAD WAS DISCARDED AND A NEW LEAD WAS PLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48247 SCREW-IN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5071-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00021 YR Other