BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR LEAD ADAPTOR - 3.2MM CONNECTOR

    MDR report key: 3243115 · Received July 18, 2013

    Report

    Report Number
    2183787-2013-00060
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 21, 2013
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTD
    PMA / PMN Number
    K870562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ADAPTER WAS ANALYZED BY THE DISTRIBUTOR OF THE ADAPTER, ST. JUDE MEDICAL. ANALYSIS FOUND THE ADAPTER HAD NORMAL CONTINUITY AND RESISTANCE. NO FRACTURES WERE FOUND. IT WAS NOTED THE RING ADAPTER SET SCREW HAD THE MED-A SEAL BROKEN OVER IT TO GAIN ACCESS TO THE SET SCREW TO UNTIGHTEN IT TO REMOVE THE LEAD. SINCE THE LEAD COULD BE REMOVED WITHOUT UNTIGHTENING THE SET SCREW, THIS MAY INDICATE THE PIN TIP ADAPTER SET SCREW WAS NOT TIGHTENED PROPERLY AT IMPLANT. A LOOSE CONNECTION WITH THE CONNECTOR PIN WOULD CAUSE THE MENTIONED ANOMALIES. THE DEVICE WAS NOT RETURNED TO GREATBATCH MEDICAL FOR ANALYSIS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT AN ADAPTER, MODEL 501214, WAS EXPLANTED DUE TO CAPTURE FAILURE. IN ADDITION, THE LEAD WAS NOT SENSING APPROPRIATELY. IT BEHAVED AS THOUGH IT WAS FRACTURED. HIGH LEAD IMPEDANCES WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335568 BIPOLAR LEAD ADAPTOR - 3.2MM CONNECTOR BIPOLAR LEAD ADAPTOR DTD GREATBATCH MEDICAL 501214

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention