BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2913302 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00060
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    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 THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE RIGHT VENTRICULAR (RV) LOSS OF CAPTURE WITH INCREASED THRESHOLD MEASUREMENTS AND A DECREASED R WAVE AMPLITUDE. A FLUOROSCOPY IMAGE WAS COMPARED TO AN X-RAY FROM IMPLANT AND NOTED NO GROSS CHANGE IN LEAD PLACEMENT, HOWEVER A MICRO-DISLODGEMENT IS SUSPECT. ALTHOUGH THE SHOCK IMPEDANCE MEASUREMENT WAS WITHIN RANGE AND STABLE, THE PHYSICIAN ELECTIVELY PERFORMED A NON-INVASIVE PROGRAMMED STIMULATION (NIPS) PROCEDURE WHICH YIELDED GOOD MEASUREMENTS. SINCE THE PATIENT IS NOT PACEMAKER DEPENDENT AND RARELY PACES IN THE VENTRICLE, THE PHYSICIAN HAS OPTED TO MONITOR THE PATIENT VIA REMOTE HOME MONITORING SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20354 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R 4480| E110| 0175