BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2169039 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-11305
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    May 23, 2011
    Report Date
    November 22, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. 510(K) # IS K062195.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED BY THE LOCAL REPRESENTATIVE THAT AFTER REPROGRAMMING THE DEVICE, THE PATIENT AND THE PHYSICIAN HAD DECIDED NOT TO REPOSITION THE LEADS. FOUR MONTHS FOLLOWING REPROGRAMMING, THE CLINIC PERFORMED AN INTERROGATION AND THE DEVICE CHECK WAS NORMAL WITH NO OTHER ISSUES. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE CLINIC IN (B)(6) 2011 THAT THIS PATIENT HAD DIED AND SHOULD BE DEACTIVATED FROM THE PATIENT MONITORING SYSTEM. THE LOCAL REPRESENTATIVE REPORTED THAT NEITHER THE CLINIC NOR THE PHYSICIAN KNEW THE EXACT CAUSE OF DEATH. HOWEVER, ACCORDING TO PHYSICIAN, THE PATIENT'S DEATH WAS NOT RELATED TO THE DEVICE OR CARDIAC IN NATURE.

    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 77 YR N119| 4555| 0184| 4086