BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2052599 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03799
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 26, 2011
    Report Date
    September 15, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION HAVE BEEN MADE. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT IN (B)(6) 2011. THE DEVICE WAS SUCCESSFULLY INTERROGATED BY BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY. A REVIEW OF THE DEVICE'S MEMORY FOUND THAT THERE WERE NO VENTRICULAR TACHYCARDIA EPISODES AND NO DELIVERED SHOCKS RECORDED ON THE DATE OF DEATH. THE DEVICE WAS PUT THROUGH AND PASSED TESTING THAT VERIFIED PACING, SENSING AND SHOCKING CAPABILITIES OF THE DEVICE. THE RECORDED SHOCK AND PACING IMPEDANCE MEASUREMENTS WERE NORMAL. THERE WAS NO EVIDENCE OF PREMATURE BATTERY DEPLETION OR LEAKY CAPACITORS. IT WAS CONCLUDED THAT THIS DEVICE PERFORMED NORMALLY THROUGHOUT LABORATORY TESTING. 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

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD DIED 32 DAYS FOLLOWING THE REPORTED HOSPITAL ADMISSION. THE LOCAL REPRESENTATIVE SPOKE TO THE PHYSICIAN AND THERE WERE NO ALLEGATIONS OR COMPLAINTS AGAINST THE DEVICES' OPERATION OR FUNCTIONALITY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A SYNCOPAL EPISODE. THE PATIENT WAS TAKEN TO THE HOSPITAL AND A VARIETY OF TESTS WERE PERFORMED. THE CAUSE OF THE SYNCOPE HAS NOT BEEN COMMUNICATED. IT WAS ALSO UNDETERMINED IF THE DEVICE HAD DELIVERED A SHOCK TO THE PATIENT PRIOR TO THE SYNCOPAL EPISODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H219

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L 0185| H215| H219| 4518| 4470