BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUNCTUA

    MDR report key: 3936161 · Received July 15, 2014

    Report

    Report Number
    2124215-2014-08914
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 5, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    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 THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE PACING LEAD IMPEDANCE MEASUREMENT THAT WAS DETECTED VIA THE PATIENT¿S REMOTE MONITORING SYSTEM. HIGH PACING THRESHOLD ON BOTH RV AND COMPETITOR'S LEFT VENTRICULAR (LV) LEADS WAS ALSO NOTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412912 PUNCTUA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND N051

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR 0148| N119| MISMATCH| T175| N051| 1790