BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3040814 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-02164
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    August 9, 2012
    Report Date
    January 4, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 WHEN REVIEWING THE ELECTROGRAM (EGM) OVERSENSING OF NOISE ON THE RIGHT ATRIAL (RA) LEAD CAUSED OVER TWO THOUSAND INAPPROPRIATE MODE SWITCHES, THE NOISE WAS REPRODUCIBLE WITH ISOMETRICS AND THE RA LEAD IMPEDANCE MEASUREMENTS WERE STABLE. THE AUTOMATIC GAIN CONTROL AND SENSITIVITY WERE ADJUSTED IN ORDER TO MITIGATE THE OVERSENSING. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH OUT OF RANGE IMPEDANCE MEASUREMENT FROM ONE MONTH EARLIER THEN CAME BACK DOWN THE VERY NEXT DAY. REVIEW OF THE LEAD'S DATA SHOWED THAT THERE HAS BEEN PERIODIC SPIKES IN THE PACE IMPEDANCE. NO OTHER MEASUREMENT ISSUES WERE OBSERVED WITH THE LEAD. AN X-RAY WAS TAKEN AND DID NOT SHOW ANY SIGNIFICANT FINDINGS. THE PHYSICIAN OPTED TO MONITOR THE PATIENT. ADDITIONAL INFORMATION WAS THAT A LITTLE OVER FOUR MONTHS LATER THERE WAS OVERSENSING OF NOISE ON THE RV AND SHOCK CHANNEL, HOWEVER NO PACING INHIBITION WAS OBSERVED. A REVISION PROCEDURE WAS PERFORMED WHERE NO ISSUES WERE SEEN WITH THE DEVICE'S HEADER UPON OPENING OF THE POCKET. THE DEFIBRILLATOR WAS EXPLANTED AND THE LEADS REMAIN IN SERVICE WITH THE NEW DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142676 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R 4087| E110| A155| 0175