BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211135 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08644
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 2, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 PACEMAKER DEPENDANT PATIENT EXPERIENCED A GREATER THAN 4 SECOND PAUSE IN PACING WHICH LEAD TO ANTI-TACHYCARDIA PACING (ATP). THERE WAS ALSO NOISE PRESENT ON THE ON THE RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD, AS WELL AS OVERSENSING ON THE RIGHT ATRIAL (RA) LEAD. THE DEVICE, THE RV AND LV LEAD WERE REMOVED AND REPLACED. A NON BOSTON SCIENTIFIC LEAD WAS USED IN THE LV THAT WOULD NOT FIT IN THE CHRONIC TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310352 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R 0181| 4555| 4054| N119