BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2780014 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13408
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 7, 2012
    Report Date
    October 31, 2023
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073/S043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 PACING IMPEDANCE MEASUREMENTS CONTINUED TO MEASURE GREATER THAN 2,000 OHMS. A DATA DISK WAS SENT IN FOR ANALYSIS. ENGINEERING ANALYSIS CONFIRMED THAT ALL VALUES WERE REPORTED AS SATURATED, WHICH COULD INDICATE A POSSIBLE LEAD FRACTURE OR SPRING LEAF DISCONNECT. THE PATIENT WAS TO BE SCHEDULED FOR AN IN CLINIC VISIT TO EVALUATE LEAD INTEGRITY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT ENGINEERING ANALYSIS COULD NOT VIEW ACTUAL IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. THE PHYSICIAN ELECTED TO CONTINUE TO MONITOR THE SYSTEM, AS GOOD SENSING AND THRESHOLD MEASUREMENTS WERE DETECTED. NO FURTHER INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED WITHIN ACCEPTABLE PACING IMPEDANCE MEASUREMENTS. A ROUTINE DEVICE CHANGE OUT PROCEDURE WAS PERFORMED, AND WHEN CONNECTED TO THE PACING SYSTEM ANALYZER (PSA) PACING IMPEDANCE MEASUREMENTS WERE GREATER THAN 2,000 OHMS. IT WAS DOCUMENTED THAT THE HELIX MAY NOT HAVE BEEN EXTENDED DURING THE PROCEDURE. ALL OTHER LEAD MEASUREMENTS WERE WITHIN ACCEPTABLE LIMITS. THE PHYSICIAN ELECTED TO CLOSE THE DEVICE POCKET AND MONITOR 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
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Hospitalization| R 0185| 4470| E163| T165| E163| T165| 4470| 0185