BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 4140038 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-16659
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    July 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 RIGHT ATRIAL (RA) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED MULTIPLE LOW PACING IMPEDANCE MEASUREMENTS OF LESS THAN 200 OHMS. OVERSENSING OF NOISE WAS ALSO OBSERVED ON THE RA CHANNEL. ADDITIONAL INFORMATION FROM THE FIELD INDICATED THAT THE SUSPECTED CAUSE OF THE IMPEDANCE AND NOISE ISSUE WAS A RA LEAD FRACTURE DUE TO A SUBCLAVIAN CRUSH, HOWEVER, THIS HAS NOT BEEN CONFIRMED THROUGH X-RAY. THE ICD WAS REPROGRAMMED AND THE SYSTEM CONTINUES TO REMAIN IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620276 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR 1861| 0158| 4087| E110