BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOOM

    MDR report key: 2167504 · Received July 19, 2011

    Report

    Report Number
    2124215-2011-08830
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 31, 2011
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    KRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROGRAMMER WAS TO BE RETURNED. 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 PROGRAMMER WAS RETURNED TO OUR QUALITY ASSURANCE LABORATORY AND UNDERWENT ANALYSIS. ANALYSIS CONCLUDED THAT THE RESISTANCE WITHIN THE TOUCH SCREEN WAS ABOVE THE NORMAL LIMITS AND WAS SUSPECTED TO CAUSE THE INTERMITTENT FAILURE AS REPORTED IN THE FIELD.

    Additional Manufacturer Narrative · 1

    THE PROGRAMMER WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A RIGHT VENTRICULAR THRESHOLD TEST OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THE HEALTH CARE PROVIDER PRESSED CANCEL ON THE PROGRAMMER SEVERAL TIMES, HOWEVER, THE THRESHOLD TEST DID NOT STOP. THERE WAS APPROXIMATELY TWO SECONDS OF ASYSTOLE BEFORE THIS DEVICE-DEPENDANT PATIENT CAME THROUGH WITH THEIR OWN RHYTHM AND THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT. THE THRESHOLD TEST CONTINUED TO STEP DOWN TO .3V. THERE WAS CONCERN REGARDING THE POTENTIAL IMPACT OF THIS TO OTHER PATIENTS. IN ADDITION, THE HEALTH CARE PROVIDER REPORTED THAT SEVERAL ATTEMPTS WERE MADE AND THE PROGRAMMER WOULD NOT RESPOND WHEN SELECTING REPORTS TO PRINT. TECHNICAL SERVICES DISCUSSED POSSIBLE SCREEN ISSUE AND RECOMMENDED USING STYLET VERSE A FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOOM KRG EXTERNAL MANUFACTURER 3120

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR 4525| H175| N118| 4469| 0184