BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2910885 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15831
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 THERE WAS OVERSENSING OF NOISE CAUSING PACING INHIBITION WITH GREATER THAN TWO SECONDS OF ASYSTOLE ON THE RIGHT VENTRICULAR (RV) CHANNEL. THE PATIENT HAD ALSO RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY, BUT NO SHOCKS DUE TO THE OVERSENSING OF NOISE. IT WAS NOTED THAT THE PATIENT WAS BEARING DOWN AT THE TIME OF THE EPISODE. THE PHYSICIAN OPTED TO ADJUST THE RV LEAD'S SENSITIVITY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17643 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR 4136| 0185| 0181| 4543| 4555| 4137| N119