BEUDAMED
    FDA Adverse Event Death Summary report: N

    BLV/BIS-10

    MDR report key: 14194555 · Received April 25, 2022

    Report

    Report Number
    1035166-2022-00061
    Event Type
    Death
    Date Received
    April 25, 2022
    Date of Event
    March 15, 2022
    Report Date
    September 15, 2022
    Manufacturer
    OSCOR INC.
    Product Code
    DTD
    UDI-DI
    00836559006411
    PMA / PMN Number
    K925168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OUR INVESTIGATION IS STILL IN PROGRESS, FOLLOW UP REPORT WILL BE SUBMITTED IF WE FIND ANY FURTHER ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THERE WAS NO ISSUE WITH ADAPTOR BLV/BIS-10 REPORTED. ITS UNKNOWN WHEN THE ADAPTOR IS IMPLANTED. CUSTOMER DID NOT PROVIDED THE CURRENT STATUS OF THE ADAPTOR OR CORRECT IMPLANT DATE . THE INVESTIGATION WAS FOCUSED ON A REVIEW OF PRODUCT DOCUMENTATION. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS.. THERE WAS NO SPECIFIC PERFORMANCE RELATED FAILURE REPORTED BY THE USER. NO FURTHER INVESTIGATION IS REQUIRED. NO FURTHER FOLLOW-UP IS REQUIRED. NO CORRECTIVE OR PREVENTIVE ACTION RESULTED AFTER INVESTIGATION OF THIS EVENT. THE EVENT WILL BE REEVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. OSCOR WILL CONTINUE TO MONITOR THIS EVENT TYPE. OSCOR INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY OSCOR INC. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT DIED DUE TO ACUTE RESPIRATORY FAILURE, COVID-19 AND CONGESTIVE HEART FAILURE. PATIENT DEATH WAS NOT RELATED TO DEVICE MALFUNCTION AND THERE WAS NO DEVICE MALFUNCTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613208 BLV/BIS-10 PACEMAKER LEAD ADAPTOR DTD OSCOR INC. BLV/BIS-10 C2-07839 00836559006411

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death