BEUDAMED
    FDA Adverse Event Injury Summary report: N

    54 CM BIPOLAR LEAD

    MDR report key: 3181460 · Received June 14, 2013

    Report

    Report Number
    2183787-2013-00052
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    K925099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: THE RETURNED DEVICE WAS VISUALLY ANALYZED. THE HELIX WAS MISSING THEREFORE HI-POT AND INNER DC RESISTANCE COULD NOT BE TESTED AS WELL AS LENGTH COULD NOT BE MEASURED. IN ADDITION, SEAL RINGS IN THE SMALL SEAL AND LARGE BOOTS ARE DAMAGED. LARGE BOOT HAS CUTS AND NICKS IN ITS BODY. ABOUT 14.2 CM AWAY FROM THE CONNECTOR END HAS RAISED FILARS AND CUTS IN THE TUBING AND ABOUT 37 CM AWAY FROM THE CONNECTOR END HAS A KINK ON THE COIL AND A CUT IN THE TUBING. THROUGHOUT THE LEAD BODY, THERE IS BROWN DRIED BODILY FLUIDS OBSERVED. THE CONNECTOR PIN LENGTH, OUTER DC RESISTANCE, AND LARGE BOOT OD WERE WITHIN SPECIFICATION. REVIEW AND CONFIRMATION OF MANUFACTURING RECORDS WAS PERFORMED. THERE IS NO INDICATION THAT THE STERILITY OF THE DEVICE WAS BREACHED. THE DEVICE MET SPECIFICATION PRIOR TO LEAVING GREATBATCH MEDICAL. A ROOT CAUSE IS NOT ABLE TO BE DETERMINED AT THIS TIME. THE DEVICE IS PART OF SEVERAL IMPLANTED COMPONENTS THAT COMPRISE A PACING SYSTEM. GREATBATCH MEDICAL IS UNABLE TO DETERMINE IF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    DEVICE WAS EXPLANTED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271560 54 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511212 W50470

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention