BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 3801357 · Received May 8, 2014

    Report

    Report Number
    2938836-2014-10929
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    March 15, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 PRESENTED IN THE HOSPITAL AFTER EXPERIENCING MULTIPLE SHOCKS. UPON ICD INTERROGATION THE SHOCK APPEARED TO BE APPROPRIATELY DELIVERED AND HIGH VOLTAGE THERAPY APPEARED TO CONVERT THE PATIENTS VF RHYTHM. DURING THE SECOND VF EPISODE HIGH VOLTAGE LEAD IMPEDANCE WAS BELOW VALUE AND AN ABORTED SHOCK DUE TO POSSIBLE HIGH VOLTAGE LEAD ISSUE WAS NOTED. THE LEAD WAS CAPPED AND REPLACED. THE PATIENT WAS FINE AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279262 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1561/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention CD2257-40, 7013232