BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2913687 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00019
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    May 17, 2011
    Report Date
    January 15, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN PERFORMED COMMANDED SHOCKS WITH A SHOCK IMPEDANCE MEASUREMENT OF 79 OHMS TO 80 OHMS. IT WAS LIKELY THAT THE PHYSICIAN WAS TO CONTINUE TO MONITOR THE DEVICE SYSTEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT SHOCK IMPEDANCE MEASUREMENTS FOR THIS DEVICE SYSTEM STEADILY INCREASED POST IMPLANT, ULTIMATELY REACHING GREATER THAN 125 OHMS. ADDITIONALLY, NOISE WAS OBSERVED ON THE SHOCK CHANNEL. FOUR UNDERSENSED BEATS WERE OBSERVED DURING DEFIBRILLATION THRESHOLD (DFT) TESTING. NON-INVASIVE PROGRAMMED STIMULATION (NIPS) PROCEDURE WAS TO BE PERFORMED TO TEST THE INTEGRITY OF THE DEVICE SYSTEM. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20821 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R E110| 4087| A155| 0185