BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2773931 · Received October 5, 2012

    Report

    Report Number
    2124215-2012-10462
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    July 4, 2012
    Report Date
    April 4, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING RECEIPT OF NEW INFORMATION THIS EVENT WILL BE FURTHER UPDATED.

    Additional Manufacturer Narrative · 1

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    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECENTLY RECEIVED THAT THE LEAD HAD BEEN TAKEN OUT OF SERVICE LAST YEAR. THE PRODUCT WAS NOT RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. SHOULD IT BE RETURNED AT A LATER DATE, LABORATORY ANALYSIS WILL BE PERFORMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE CLINICAL FOLLOW-UP, HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS, NOISE AND OVERSENSING, WERE EXHIBITED WITH THIS RIGHT VENTRICULAR LEAD. INITIALLY, THE OBSERVED CLINICAL OBSERVATIONS WERE SUSPECTED TO HAVE BEEN RELATED TO THE ASSOCIATED DEVICE, AS IT WAS SUSPECTED THE HEADER BONDING MAY HAVE BEEN COMPROMISED. TO DATE, THE LEAD AND ASSOCIATED DEVICE REMAIN IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1