BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL TR

    MDR report key: 3904390 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09459
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 4, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 THERE WAS A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT OF GREATER THAN 2500 OHMS EXHIBITED ON THIS PATIENT¿S LEFT VENTRICULAR (LV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). THERE WAS ALSO NO CAPTURE AT MAXIMUM OUTPUTS ON THE LV LEAD. THE PHYSICIAN BELIEVED THAT THE LV LEAD IS FRACTURED, HOWEVER THIS WAS NOT CONFIRMED WITH EITHER X-RAY OR FLUOROSCOPY. THERE WAS NO ASYSTOLE OR PAUSES NOTED AND THE PATIENT WAS NOT SYMPTOMATIC. THE PATIENT¿S CRT-P WAS REPROGRAMMED TO RIGHT VENTRICULAR PACING ONLY AND NO INTERVENTION WAS PERFORMED. THE SYSTEM CONTINUES TO REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383861 CONTAK RENEWAL TR IMPLANTABLE CHF GENERATOR DTB GUIDANT CRM CLONMEL IRELAND H140

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 4542| 4137| H140| 4136