BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1870056 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17524
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 19, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003
    Removal / Correction Number
    Z-0187-06 THRU Z-0190-06
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS PACEMAKER EXPERIENCED AN EPISODE OF SYNCOPE. UPON TESTING IN THE HOSPITAL, NOISE WAS OBSERVED AND THE SENSITIVITY OF THE PACEMAKER WAS REPROGRAMMED. THE FIELD REPRESENTATIVE HAD CONTACTED TECHNICAL SERVICES (TS) AND REPORTED UNDERSENSING AND ATRIAL FIBRILLATION. THE PATIENT'S DAUGHTER REPORTED THAT A SIMILAR SYNCOPAL EPISODE HAD OCCURRED SIX MONTHS PRIOR WITH A HEART RATE OF APPROXIMATELY 48 BEATS PER MINUTE (BPM). IN ADDITION, THE PATIENT'S DAUGHTER REPORTED THAT THE PATIENT HAD COLLAPSED TWO WEEKS PRIOR AFTER HAVING BURNING IN HIS CHEST. AT THAT TIME, A FAST HEART RHYTHM WAS DISCOVERED AND A CARDIOVERSION WAS SCHEDULED HOWEVER THE RHYTHM CONVERTED ON ITS OWN. THE PATIENT WAS DISCHARGED AND SENT HOME. THERE WERE NO FURTHER ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening (B)(4)| (B)(4)| 1298| (B)(4)