BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 6026806 · Received October 13, 2016

    Report

    Report Number
    2124215-2016-12414
    Event Type
    Injury
    Date Received
    October 13, 2016
    Date of Event
    July 6, 2016
    Report Date
    July 14, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD HAS BEEN RETURNED. BOSTON SCIENTIFIC HAS CONCLUDED IT IS UNLIKELY THAT LEAD CHARACTERISTICS CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. 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 VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING THRESHOLD MEASUREMENTS. MOREOVER, THERE WAS POSSIBLE MICRO DISLODGEMENT OBSERVED. ADDITIONAL INFORMATION OBTAINED FROM THE FIELD WHICH INDICATED THAT THE THRESHOLD CONTINUED TO RISE AFTER IMPLANT AT MAXIMUM OUTPUT ON THE DEVICE TO CAPTURE. A DISLODGEMENT WAS NOT EVIDENT ON X-RAY SO THE PHYSICIAN SUSPECTED A MICRO DISLODGEMENT. MOREOVER, THERE WAS SOME LOSS OF CAPTURE NOTED POST IMPLANT AND SUBSEQUENTLY SET OUTPUT TO THE MAXIMUM. THE LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679978 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| L| R 4088| 4470| L301