BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1850168 · Received October 1, 2010

    Report

    Report Number
    2124215-2010-13815
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    July 2, 2010
    Report Date
    July 22, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS LEAD'S REPORTING STATUS IS CHANGED TO SERIOUS INJURY FROM MALFUNCTION DUE TO REPLACEMENT TO RESOLVE A SUSPECTED MALFUNCTION. THIS REPORT WILL BE UPDATED IF THE LEAD IS EXPLANTED AND RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM A HEALTH CARE PROVIDER (HCP) THAT THIS LEAD HAD TRIGGERED A REMOTE MONITORING ALERT FOR A HIGH OUT-OF-RANGE SHOCK IMEPDANCE. HCP TOLD A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) THAT THE IMPEDANCE HAD BEEN GRADUALLY INCREASING SINCE IMPLANT, AND THERE WAS EVIDENCE OF NOISE ON THE SHOCK CHANNEL FROM AN ELECTROGRAM. TS DISCUSSED THE POSSIBILITY OF A LEAD CRUSH THAT HAD DEVELOPED INTO A FRACTURE, POSSIBLY RELATED TO MOVEMENT OF THE PROXIMAL END OF THE LEAD AT THE LAST DEVICE CHANGEOUT. TS ALSO DISCUSSED TROUBLESHOOTING TECHNIQUES TO TEST THE LEAD'S INTEGRITY. NO ADVERSE PATIENT EFFECTS WERE REPORTED, AND THE LEAD REMAINS IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    THE LEAD SUBSEQUENTLY WAS SURGICALLY ABANDONED AND REPLACED WITH A LEAD FROM ANOTHER MANUFACTURER. THERE WERE NO REPORTS OF ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR N119| 0184| 4087