BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASSIVE PLUS DX

    MDR report key: 2014001 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01342
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    January 18, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960030
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED GREATER THAN 2000 OHMS IMPEDANCE IN BOTH CONFIGURATIONS. CAPTURE THRESHOLDS HAD RISEN TO 3.5 V, 1 MS. THERE WAS SOME NOISE VISIBLE AND THE DEVICE WAS SENSING IT. THE LEAD WAS CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASSIVE PLUS DX PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1346T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention