BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2170367 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-10864
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    May 30, 2011
    Report Date
    October 24, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP PROCEDURE WAS SCHEDULED TO EVALUATE THE SYSTEM. THIS REPORT WILL BE UPDATED ONCE ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN DEACTIVATED THE IMPLANTED SYSTEM. THE SYSTEM WAS NOT EXPLANTED DUE TO THE PATIENT'S TUMOR DISEASE. THE PATIENT RECEIVES PALLIATIVE THERAPY. THE DECISION WAS MADE TO NOT EXPLANT THE SYSTEM, BECAUSE THE PAIN TO DIE FROM A CARDIAC ARREST IS LESS SEVERE THAN TO DIE FROM THE TUMOR DISEASE. 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 THIS RIGHT VENTRICULAR (RV) LEAD HAD INTERMITTENT PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. AN ELEVATED PACING THRESHOLD AND OVERSENSING OF NOISE WAS ALSO OBSERVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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