BEUDAMED
    FDA Adverse Event Death Summary report: N

    54CM BIPOLAR LEAD

    MDR report key: 2706478 · Received August 16, 2012

    Report

    Report Number
    2183787-2012-00059
    Event Type
    Death
    Date Received
    August 16, 2012
    Report Date
    August 15, 2012
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    K925099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS ANALYZED FOR INSULATION INTEGRITY, DC RESISTANCE AND DIMENSIONAL REQUIREMENTS. RESULTS DEMONSTRATED THAT DEVICE MET ALL SPECIFICATIONS. ALL TRACEABILITY AND PROCESS CONTROLS WERE REVIEWED AND EVIDENCE INDICATED THAT THIS DEVICE MET ALL SPECIFICATIONS PRIOR TO LEAVING GREATBATCH MEDICAL. UNABLE TO DETERMINE WHETHER THE EVENT WAS RELATED TO DEVICE PERFORMANCE, PT CONDITION, OR SURGICAL TECHNIQUE. THE RETURNED DEVICE MET ALL GREATBATCH MEDICAL DIMENSIONAL, ELECTRICAL AND VISUAL REQUIREMENTS.

    Description of Event or Problem · 1

    RECEIVED INFO THAT DURING AN EPICARDIAL LEFT VENTRICULAR (LV) LEAD IMPLANT PROCEDURE, THE LEAD WAS PLACED HOWEVER THE FIRST POSITION DID NOT YIELD GOOD MEASURED DATA SO THE PHYSICIAN ELECTED TO REPOSITION THE LEAD. WHEN THE LEAD WAS REMOVED, A PERFORATION WAS OBSERVED IN THE LV WALL. THE PT PASSED AWAY AS A RESULT OF THE EPICARDIAL LV LEAD IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 54CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511212 W1719000

    Patients

    Seq Age Sex Outcome Treatment
    1 Death