BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3053645 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05430
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    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 DURING A ROUTINE FOLLOW-UP APPOINTMENT, ONE PACING IMPEDANCE MEASUREMENT WAS BELOW 200 OHMS ON THE RIGHT VENTRICULAR (RV) LEAD. THE PACING MEASUREMENT WAS APPROPRIATE; HOWEVER, THE SENSING MEASUREMENT WAS NOT AVAILABLE AS THE PATIENT HAD NO SPONTANEOUS RHYTHM. TWO EPISODES OF NOISE WERE NOTED. IN BOTH EPISODES, THE NOISE WAS OVERSENSED RESULTING IN INHIBITION. FLUOROSCOPY NOTED THE LEAD WAS POSITIONED SEPTALLY, VERY CLOSE TO THE ATRIUM. AS A RESULT, THE LEAD WAS REPOSITIONED IN THE APICAL POSITION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154450 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R