BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2153575 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06552
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    March 30, 2011
    Report Date
    February 21, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE CLINICAL FOLLOW-UP, HIGH OUT OF RANGE SHOCK IMPEDANCE VALUES HAD BEEN EXHIBITED, WITH A NOTABLE UPWARD TREND SINCE IMPLANT. IT WAS FURTHER REPORTED THAT PACING, SENSING AND LEAD PACING IMPEDANCES WERE UNREMARKABLE AND INDUCTION TESTING AT THE TIME OF IMPLANT RETURNED ACCEPTABLE VALUES. PRESSURE TESTING WAS THEN PERFORMED, EXCLUDING A LEAD MECHANICAL ISSUE WITH NO NOISE PRESENTING ON THE ELECTROGRAM AND FAVORABLE VALUES EXHIBITED. BOSTON SCIENTIFIC TECHNICAL SERVICES REVIEWED THE INFORMATION OF THIS CASE AND CONCLUDED THAT NO LEAD MECHANICAL FAILURES WERE PRESENT. IT WAS RECOMMENDED THE PATIENT BE EVALUATED WITH A MAXIMUM ENERGY SHOCK TO VERIFY IMPEDANCE VALUES. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND NO COMMUNICATION ON ANY PLANNED INTERVENTION AT THIS TIME.

    Description of Event or Problem · 1

    DURING A RECENT CLINICAL FOLLOW-UP, HIGH OUT OF RANGE SHOCK IMPEDANCE VALUES WERE AGAIN OBSERVED. THE PHYSICIAN PERFORMED A SYNCHRONOUS SHOCK (1.1 JOULE), WHICH RETURNED A SHOCK IMPEDANCE VALUE OF 94 OHMS. THE PHYSICIAN ELECTED TO NOT PERFORM ANY FURTHER TESTING AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    DURING A RECENT CLINICAL FOLLOW-UP, HIGH OUT OF RANGE SHOCK IMPEDANCE VALUES WERE AGAIN OBSERVED. THE PHYSICIAN PERFORMED A SYNCHRONOUS SHOCK (1.1 JOULE), WHICH RETURNED A SHOCK IMPEDANCE VALUE OF 94 OHMS. THE PHYSICIAN ELECTED TO NOT PERFORM ANY FURTHER TESTING AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENTLY, THE PATIENT RETURNED FOR EVALUATION AT WHICH TIME, A COMMANDED SHOCK WAS INITIATED AND IMPEDANCES MEASURED. THE RETURNED VALUES WAS 78 OHMS (NORMAL RANGE), THUS NO FURTHER INTERVENTION PERFORMED AND INFORMATION STATES THE PATIENT WILL BE FOLLOWED REMOTELY FOR ANY CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R