BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 4132322 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-16806
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 12, 2014
    Report Date
    July 17, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE REMOTE HOME MONITORING SYSTEM ISSUED AN ALERT FOR HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS BROUGHT INTO THE PHYSICIAN'S OFFICE WHERE HIGH OUT OF RANGE IMPEDANCES WERE OBSERVED WHEN PROGRAMMED IN TRIAD CONFIGURATION. WHEN THE VECTOR WAS PROGRAMMED RV TO CAN THE IMPEDANCE WAS WITHIN RANGE AT 79 TO 80 OHMS, THUS IT WAS REPROGRAMMED. A LOOSE SETSCREW WAS THE SUSPECTED CAUSE. THE PATIENT WAS BROUGHT IN FOR NON-INVASIVE PROGRAMMED STIMULATION (NON-INVASIVE PROGRAMMED STIMULATION (NIPS) TESTING WHERE WHEN TESTED IN SINGLE COIL CONFIGURATION, THE SHOCK IMPEDANCE MEASUREMENT WAS WITHIN RANGE. THE DEVICE WAS LEFT PROGRAMMED IN A SINGLE COIL CONFIGURATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613203 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND N141

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R N141| 4470| MISMATCH| T180| 0175