BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2913306 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00585
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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 NEWLY IMPLANTED RIGHT VENTRICULAR (RV) LEAD HAD SOME OVERSENSING AND NOISE NOTED. IT IS UNKNOWN WHAT THE SOURCE OF THE NOISE WAS, BUT IT WAS BELIEVED TO BE DIAPHRAGMATIC IN NATURE. THERE WAS ALSO A PAUSE IN PACING INVOLVING THIS LEAD THAT LASTED LONGER THAN TWO SECONDS AND RESULTED IN A NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODE. THERE WERE NO ADVERSE PATIENT EFFECTS FROM THIS PAUSE IN PACING AND THE LEAD HAS SINCE OPERATED APPROPRIATELY. NO ADDITIONAL INTERVENTIONS WERE REQUIRED. THE LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19882 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR N119| 0157| 0180| 1888TC| 4470| A135| 4555| E030