BEUDAMED
    FDA Adverse Event Injury Summary report: N

    35 CM BIPOLAR LEAD

    MDR report key: 3812807 · Received May 6, 2014

    Report

    Report Number
    2183787-2014-00047
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    February 7, 2014
    Report Date
    April 25, 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

    NA

    Description of Event or Problem · 1

    THE PATIENT WAS REFERRED FOR PACEMAKER IMPLANTATION AFTER AN UNSUCCESSFUL ATTEMPT TO IMPLANT A TRANSVENOUS PACEMAKER FOR 2ND DEGREE HB. THE PATIENT UNDERWENT ANOTHER PROCEDURE TO PLACE AN EPICARDIAL PACEMAKER THROUGH A SUB-XIPHOID APPROACH. THIS LEAD WAS INITIALLY PLACED WITHOUT DIFFICULT BUT SUBSEQUENTLY REPOSITIONED DUE TO INABILITY TO CAPTURE AT 10.0V/0.5 MS. AFTER REPOSITIONING, CAPTURE WAS DEMONSTRATED AT 1.2V/0.5 MS. FINAL I/O TESTING WAS UNCOMPLICATED AND FOUND TOT HAVE 4.7 MS R-WAVE/45 OHM (UNI) / 1.75 V AT 0.6 MS PW CAPTURE THRESHOLD. MODE VVI 50/ 5.0V/0.6 MS. THE PATIENT WAS SUCCESSFULLY DISCHARGED TO THE RECOVERY ROOM. A PHONE CALL WAS RECEIVED FORM THE RECOVERY ROOM TO INFORM TSS THAT THEY WERE CODING THE PATIENT. TSS ARRIVED TO INTERROGATE THE PACEMAKER AND FOUND THE PACEMAKER NOT ABLE TO CAPTURE AT MAX AMPLITUDE AND A LOW AMPLITUDE R-WAVE. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO THE CARDIAC ICU. RE-EVALUATION OF PACING AND SENSING THRESHOLDS BY TSS FOUND THE PACEMAKER WAS STILL UNABLE TO CAPTURE. THE IMPLANTING PHYSICIAN, (B)(6) SUGGESTED THAT CPR THAT WAS PERFORMED MAY HAVE DISLODGED THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271143 35 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511211 W2551461

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention