BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE-FIXATION LEAD

    MDR report key: 724962 · Received June 7, 2006

    Report

    Report Number
    2938836-2006-00424
    Event Type
    Injury
    Date Received
    June 7, 2006
    Date of Event
    May 25, 2006
    Report Date
    May 25, 2006
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IN ITS ENTIRETY WAS COMPLETED SOLELY BY ST. JUDE MEDICAL, INC., CRMD.

    Description of Event or Problem · 1

    THE ST. JUDE MEDICAL REP PHONED TO REPORT THAT THE PT RECEIVED MULTIPLE INAPPROPRIATE THERAPIES AND ABORTED THERAPIES. THE PT HAD BEEN LOST TO FOLLOW-UP. PACING LEAD IMPEDANCE WAS LOW COMPARED TO MEASUREMENTS TAKEN AT IMPLANT. ST. JUDE MEDICAL TECHNICAL SERVICES REVIEWED THE FAXED ELECTROGRAMS AND CONFIRMED INAPPROPRIATE THERAPY. A POSSIBLE INSULATION BREAK OR LEAD FRACTURE WAS DISCUSSED. THE ST. JUDE MEDICAL REP DISCUSSED THE CASE WITH THE PHYSICIAN AND IT WAS DECIDED TO TURN THE DEVICE OFF TEMPORARILY. IT WAS LATER REPORTED THAT THE LEAD WAS CAPPED AND REPLACED. THE DEVICE WAS ALSO EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE-FIXATION LEAD DEFIBRILLATION LEAD LWS ST. JUDE MEDICAL, INC., CRMD 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention