BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2781105 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13482
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 25, 2012
    Report Date
    November 26, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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

    AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE ENTIRE SYSTEM WAS EXPLANTED DUE TO A SKIN INFECTION THAT LEAD TO A POCKET EROSION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS DURING THE COMMANDED SHOCKING LEAD IMPEDANCE TEST WHILE THE PATIENT WAS IN THE OFFICE. IT WAS NOTED THAT NO OUT OF RANGE MEASUREMENTS WERE OBSERVED ON THE DAILY MEASUREMENTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED SENDING A DISK OF THE DEVICE'S MEMORY. UPON REVIEW OF THE DEVICE'S MEMORY, ENGINEERING NOTED NO ISSUES WITH THE SYSTEM. FURTHER DISCUSSION WITH THE FIELD REPRESENTATIVE DETERMINED THAT THE DEVICE HAD MIGRATED INTO THE PATIENT'S BREAST TISSUE, WHICH MAY HAVE CONTRIBUTED TO THE OUT OF RANGE IMPEDANCE VALUES. ULTIMATELY IT WAS DETERMINED THAT THE WAY THE COMMANDED SHOCK IMPEDANCE ALGORITHM IS CONSTRUCTED WAS THE PROBABLE CAUSE OF OUT OF RANGE IMPEDANCE. NO INTERVENTION WAS TAKEN AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R N160| 0295| MISMATCH