BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYOPORE SUTURELESS MYOCARDIAL PACING LEAD 54CM

    MDR report key: 4144326 · Received September 23, 2014

    Report

    Report Number
    2183787-2014-00111
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    July 26, 2014
    Report Date
    July 26, 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT PRESENTED WITH SYNCOPE DUE TO LEAD NOISE AND INHIBITION. THE PT WAS BROUGHT IN FOR LEAD REPLACEMENT AND AFTER OPENING THE POCKET THE PHYSICIAN STATED THERE WAS AN ABRASION AT THE YOKE OF THE NON-GREATBATCH LEAD. THE LEAD PRESENTED WITH CAPTURE OF 135V AT 1.0 MS, 580 OHM PLI AND 49 OMH HVLI. THE RV LEAD WAS LEASER LEAD EXTRACTED SUCCESSFULLY WITHOUT COMPLICATION AND WAS REPLACED WITH ANOTHER LEAD. THE GENERATOR WAS ELECTIVELY REPLACED WITH ANOTHER DEVICE. THE GREATBATCH LV LEAD INTERMITTENTLY CAPTURED AT MAXIMUM OUTPUT AND HAD IMPEDANCE 390 OHMS TIP-RVC. THE LV LEAD WAS CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591192 MYOPORE SUTURELESS MYOCARDIAL PACING LEAD 54CM BIPOLAR EPICARDIAL LEAD, 21 CFR 870.3680 DTB GREATBATCH MEDICAL 511212 W1361808

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention