BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35 CM BIPOLAR LEAD

    MDR report key: 3980214 · Received June 5, 2014

    Report

    Report Number
    2183787-2014-00074
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 22, 2014
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    P130012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS ACTIVE LV LEAD WAS FOUND TO HAVE IMPEDANCES LESS THAN 200OHMS. NOISE WAS ALSO SEEN ON THE STORED EGMS. CAPTURE THRESHOLD WAS UNKNOWN SINCE NOISE ON THE LV UNIPOLAR CHANNEL MADE IT DIFFICULT TO ASSESS CAPTURE. THE PHYSICIAN OPENED THE POCKET TO UNCAP THE OTHER IMPLANTED LEAD. PSA TESTING SHOWED NORMAL LEAD FUNCTION, SO IT WAS CONNECTED TO THE LV PORT WHERE IMPEDANCES OG GREATER THAN 3000OHMS WERE SEEN. NOISE WAS ALSO SEEN ON THE LV CHANNELS. IMPEDANCES BECAME VARIABLE, MEASURING LESS THAN 200OHMS. THE PHYSICIAN CLEANED OFF THE PIN AND USED A SYRINGE TO INJECT AIR INTO THE LV PORT. THE LEAD WAS RECONNECTED AND CONTINUED TO SHOW NOISE AND IMPEDANCES OVER 3000OHMS. THE ATRIAL LEAD WAS THEN CONNECTED TO THE LV PORT AND SHOWED NORMAL NUMBERS WITH NO NOISE. PSA TESTING CONTINUED TO SHOW NORMAL NUMBERS ON THE LV LEAD. MINERAL OIL WAS APPLIED TO THE LV PIN. THE PIN WAS REINSERTED AND INITIALLY REPORTED IN RANGE IMPEDANCES AROUND 400. THE IMPEDANCES THEN FELL BACK OUT OF RANGE ABOVE 3000. THE PHYSICIAN RESET THE SET CREW AND SAW NORMAL IMPEDANCES AROUND 400. HE CLOSED THE POCKET AND HAS SEEN NORMAL READING SINCE. THE PHYSICIAN'S CONFIDENCE IN THE SYSTEM IS LOW. THE PATIENT WILL BE CLOSELY MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330421 35 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511211 W1541418

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention