BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 3213073 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10320
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 15, 2013
    Report Date
    October 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING COMPLETION OF LAB ANALYSIS, THIS EVENT WILL BE FURTHER UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS SYSTEM WAS HOSPITALIZED FOR A NON-CARDIAC RELATED CONDITION. DURING HOSPITAL ADMISSION, THE PATIENT REPORTEDLY EXHIBITED A VENTRICULAR FIBRILLATION (VF) RATE; HOWEVER, THE DEVICE FAILED TO DELIVER THERAPY. EXTERNAL DEFIBRILLATION AND CPR WERE PERFORMED: SYSTEM UNDERSENSING WAS SUSPECTED. ADDITIONALLY, IT WAS REPORTED THE PHYSICIAN MISPLACED THE PRINTED EPISODES, THUS NO TECHNICAL REVIEW WAS PERFORMED. DURING A SUBSEQUENT DEVICE INTERROGATION, NO EPISODES FROM THIS DATE (OR SURROUNDING DATES) WERE OBSERVED. BOTH THE RIGHT AND LEFT VENTRICULAR LEADS, ALONG WITH THE DEVICE, WERE EXPLANTED. ANOTHER SYSTEM WAS IMPLANTED WITH FAVORABLE MEASUREMENTS OBSERVED. ALL PRODUCTS ARE EXPECTED TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312048 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND P142

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R