BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYOCARDIAL LEAD

    MDR report key: 3990487 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08631
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K031274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. PRODUCTS: 694765 LEAD; IMPLANTED 2009 (B)(6); (B)(4) ICD; IMPLANTED 2011 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR  (ICD) BATTERY ONLY LASTED TWO AND A HALF YEARS BECAUSE OF THE NEED FOR HIGH OUTPUT DUE TO PATIENT ANATOMY. IT WAS NOTED THAT THE CHRONIC LEFT VENTRICULAR (LV) LEAD HAD LOW IMPEDANCE. THIS LV LEAD REMAINS IN USE. DURING THE REPLACEMENT PROCEDURE, A CAPPED LV LEAD WAS UNCAPPED IN ORDER TO TEST THE LEAD. DURING THE PROCEDURE, THE CONNECTOR PIN CAME OFF WITH THE CAP. THE LV LEAD WAS RECAPPED AND REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472588 MYOCARDIAL LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5071-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R 5076-52 LEAD, 5071-53 LEAD