BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2170327 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09668
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    May 31, 2011
    Report Date
    July 21, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THESE PRODUCTS REMAIN IN SERVICE. 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

    IT WAS LATER REPORTED THAT PACING INHIBITION HAD OCCURRED. INSULATION ISSUES AND A VISIBLE FRACTURE WERE ALSO REPORTED ON THE LEAD. AS A RESULT THIS LEAD WAS EXPLANTED AND WILL BE RETURNED. THE DEVICE REMAINS IMPLANTED. 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 THIS PACEMAKER DETECTED NOISE ON THE RIGHT VENTRICULAR LEAD. THIS NOISE WAS SEEN IN UNIPOLAR CONFIGURATION BUT NOT IN BIPOLAR. HOWEVER, WHEN THE DEVICE WAS PROGRAMMED TO BIPOLAR THERE WAS NO CAPTURE AND NO SENSING. THE LEAD MEASUREMENTS WERE NORMAL. THIS PATIENT WAS AN AVID GOLFER AND HAD NO SYMPTOMS. THE PHYSICIAN ELECTED TO PROGRAM THE DEVICE TO PACE BIPOLAR AND SENSE UNIPOLAR. AN X-RAY WAS PERFORMED, BUT DID NOT REVEAL ANYTHING. THE PATIENT WILL BE FURTHER EVALUATED IN ONE MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S601

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR S601| 4137