BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911912 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16899
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 10, 2012
    Report Date
    December 6, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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 VENTRICULAR (RV) LEAD EXHIBITED NOISE AND OVERSENSING. THE OVERSENSING DID NOT RESULT IN GREATER THAN TWO SECONDS OF ASYSTOLE. IT WAS ALSO REPORTED THAT THE IMPEDANCES WERE VARYING BETWEEN 400 AND 1,300 OHMS AND THE PACING THRESHOLDS WERE INCREASING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT UNDERWENT IN-OFFICE LEAD TESTING AND THE NOISE/OVERSENSING WAS UNABLE TO BE REPRODUCED AND IMPEDANCES WERE FOUND TO BE STABLE. THE PHYSICIAN CHOSE TO EXTEND DURATION AND CONTINUE TO MONITOR THIS PATIENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18264 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR S602| 4524| 0185| 4555| 4024| 1286| MISMATCH| N141