BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE SG

    MDR report key: 13049174 · Received December 20, 2021

    Report

    Report Number
    2124215-2021-36940
    Event Type
    Injury
    Date Received
    December 20, 2021
    Date of Event
    October 15, 2021
    Report Date
    December 20, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVY
    UDI-DI
    00802526531248
    PMA / PMN Number
    P910073/S077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER PERTINENT INFORMATION BE PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO OVERSENSING, HIGH, OUT OF RANGE SHOCK IMPEDANCE AND HIGH PACING IMPEDANCES. ALSO, HIGH PACING THRESHOLDS WERE OBSERVED. NO PACING INHIBITION WAS OBSERVED. A NEW RV LEAD WAS IMPLANTED AT THE SAME SURGICAL INTERVENTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946972 ENDOTAK RELIANCE SG IMPLANTABLE LEAD NVY BOSTON SCIENTIFIC CORPORATION 0292 442604 00802526531248

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention| H