BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2173363 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11187
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 11, 2011
    Report Date
    July 18, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    THE ABANDONED LEAD HAS NOT BEEN RETURNED FOR ANALYSIS THEREFORE BOSTON SCIENTIFIC CANNOT CONFIRM THIS CLINICAL OBSERVATION. 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 DEFIBRILLATION LEAD AND DEVICE DISPLAYED OUT OF RANGE HIGH IMPEDANCE MEASUREMENTS AND NOISE. THE NOISE RESULTED IN OVERSENSING AND THE STORAGE OF MANY NON-SUSTAINED EPISODES. THE RATE SENSE PORTION OF THE LEAD WAS ABANDONED AND REPLACED. THE SHOCKING PORTION OF THE LEAD REMAINS IN USE. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE OVERSENSING OR THE PROCEDURE.

    Description of Event or Problem · 1

    OUR COMPANY RECEIVED ADDITIONAL INFORMATION FROM THE PATIENT ONE MONTH LATER THAT THE LEAD WIRE HAD A CRACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R H135| 6744| 4513| H177| N119| 4469| 4046| 0158