BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 3890499 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-04490
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    December 13, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT CAME TO THE CLINIC AFTER RECEIVING A PT NOTIFICATION. UPON INTERROGATION THE DEVICE REPORTED LOW OUT OF RANGE HIGH VOLTAGE LEAD IMPEDANCE. THE LEAD REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30221 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD, NVY NVY ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D 1571/65

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR