BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211595 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09047
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 1, 2013
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FROM A FIELD REPRESENTATIVE REVEALED THIS LEAD WAS CUT DURING THE EXTRACTION AND WILL NOT BE RETURNED. 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

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT NOISE WAS NOTED ON THIS RIGHT VENTRICULAR (RV) LEAD, WHICH LEAD TO OVERSENSING AND THE PATIENT RECEIVING FIVE INAPPROPRIATE SHOCKS. NO NOTED THERAPY EXHAUSTION INVOLVING THE DEVICE. THE SOURCE OF THE NOISE WAS UNKNOWN AND ALL OTHER LEAD NUMBERS AND MEASUREMENTS WERE NORMAL. THE PHYSICIAN SUSPECTS THIS MIGHT BE DUE TO A COMPROMISE IN THE LEAD INSULATION PROXIMAL TO THE PROXIMAL COIL. SURGICAL INTERVENTION WAS PERFORMED TO EXPLANT THIS LEAD AND REPLACE IT WITH A NEW RV LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310328 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R 4470| E110| 0185| 4136| T165