BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASSIVE PLUS DX

    MDR report key: 3923217 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14531
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    April 30, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    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 PATIENT EXPERIENCE SYNCOPE AND FELL HITTING HIS HEAD. UPON INTERROGATION THE RIGHT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE AND LOW LEAD IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401611 PASSIVE PLUS DX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1346T/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention