BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF DR

    MDR report key: 1050933 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01872
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    March 27, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND THAT THE DEVICE HAD A POSSIBLE SHORTED HV OUTPUT (SOSD) WARNING UPON INTERROGATION. DEVICE DIAGNOSTICS SHOWED THAT THE DEVICE DELIVERED TWO SUBSEQUENT SHOCKS NORMALLY. TESTING IN THE AUTOMATED ELECTRICAL TEST SYSTEM FOUND NO ANOMALIES AND THE DEVICE MET ALL SPECIFICATIONS. A FALSE SOSD MAY OCCUR WHEN THE VOLTAGE ON THE LEADS DOES NOT DROP FAST ENOUGH AFTER THE DELIVERY OF A HIGH VOLTAGE SHOCK AND THE VOLTAGE STILL EXCEEDS THE SOSD THRESHOLD WHEN THE LEAD VOLTAGE IS MEASURED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DISPLAYED AN ALERT STATING "POSSIBLE HV CIRCUIT DAMAGE". THE DEVICE DELIVERED APPROPRIATE HV THERAPY AFTER THE ALERT OCCURRED. THE THERAPY OCCURRED WHILE THE PATIENT WAS UNDERGOING A CAT SCAN. THE PATIENT WAS ALSO EXPOSED TO EXTERNAL DEFIBRILLATION AFTER THE DEVICE DELIVERED THERAPY. THE DEVICE WAS REMOVED.

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: BLOOD PUMP. INFLOW CANNULA MALPOSITION SINCE WEIGHT LOSS. SPECIFIC COMPONENT(S) INVOLVED: INFLOW GRAFT MALFUNCTION/MALPOSITION. CANNULA HAS MOVED LATERALLY. CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIED. INTERVENTION(S): NONE. IMPLANT DEVICE TYPE: LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT RF DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention