BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4140030 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-16973
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    August 29, 2014
    Report Date
    January 9, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO FURTHER INFORMATION CONCERNING THIS CASE WAS MADE AVAILABLE FROM THE FIELD DESPITE MULTIPLE ATTEMPTS TO GAIN ADDITIONAL INFORMATION. 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

    (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

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT¿S RIGHT VENTRICULAR (RV) LEAD AND DEVICE WERE OVERSENSING NOISE WHICH ALMOST CAUSED INAPPROPRIATE THERAPY. A SLIGHT DOWNWARD TREND IN PACING IMPEDANCES WAS ALSO OBSERVED, HOWEVER NO MEASUREMENTS WERE OUT OF RANGE. MYOPOTENTIAL TESTING AND ISOMETRICS WAS ABLE TO REPRODUCE THE NOISE AND THE PHYSICIAN BELIEVES THE RV LEAD IS FRACTURED DUE TO A SUBCLAVIAN CRUSH. ADDITIONAL INFORMATION FROM THE FIELD INDICATED THAT THIS FRACTURE HAS NOT BEEN DETERMINED THROUGH EITHER X-RAY OF FLUOROSCOPY. THE PATIENT¿S SYSTEM WAS REPROGRAMMED AND A REVISION PROCEDURE WILL TAKE PLACE WITHIN THE NEXT FEW MONTHS, ALTHOUGH NO SPECIFIC DATE HAS BEEN GIVEN. THE RV LEAD AND DEVICE CONTINUE TO REMAIN IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620698 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0165

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR 0165| 4574| 1861