BEUDAMED
    FDA Adverse Event Death Summary report: N

    35 CM BIPOLAR LEAD

    MDR report key: 3723922 · Received February 26, 2014

    Report

    Report Number
    2183787-2014-00037
    Event Type
    Death
    Date Received
    February 26, 2014
    Date of Event
    December 23, 2013
    Report Date
    March 21, 2014
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    P130012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A 4.0 CM PORTION OF THE CONNECTOR END WAS RETURNED FOR ANALYSIS. THE CONNECTOR PIN LENGTH AND LARGE BOOT WERE BOTH WITHIN SPECIFICATION. VISUALLY THE PARTIAL RETURNED DEVICE WAS OK. REVIEW AND CONFIRMATION OF MANUFACTURING RECORDS WAS PERFORMED. ALL RECORDS INDICATE THE DEVICE MET SPECIFICATION PRIOR TO LEAVING GREATBATCH MEDICAL. A ROOT CAUSE IS NOT ABLE TO BE DETERMINED AT THIS TIME SINCE THE FULL DEVICE WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, THERE WERE NO ALLEGATIONS AGAINST THE PRODUCT. NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THERE IS NO EVIDENCE TO SUGGEST THE DEVICE DID NOT MEET SPECIFICATION PRIOR TO LEAVING GREATBATCH MEDICAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PT DEATH. DEATH DATE WAS TAKEN FROM THE DISTRIBUTOR'S PT HISTORY. GREATBATCH MEDICAL ATTEMPTED TO OBTAIN MORE INFO FROM THE HOSPITAL PROVIDED BY THE DISTRIBUTOR. HOWEVER, THE HOSPITAL HAD NO RECORD OF EXPLANTING THE DEVICE. NO CAUSE OR ALLEGATION AGAINST ANY IMPLANTED PRODUCT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118566 35 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511211 W1453005

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death