BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD ADAPTOR

    MDR report key: 11975361 · Received June 10, 2021

    Report

    Report Number
    1035166-2021-00060
    Event Type
    Injury
    Date Received
    June 10, 2021
    Date of Event
    April 16, 2021
    Report Date
    November 5, 2021
    Manufacturer
    OSCOR INC
    Product Code
    DTD
    UDI-DI
    00885672008277
    PMA / PMN Number
    K925168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS USED FOR TREATMENT. THE DEVICE WAS NOT RETURNED. THE ADAPTOR WAS IMPLANTED FOR 1 DAY BEFORE BEING EXPLANTED ON (B)(6) 2021. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICES PASSED ALL APPLICABLE IN PROCESS AND FINAL INSPECTIONS THERE WAS NO PRODUCT PERFORMANCE ISSUE REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING DIFFERENT LEADS AND ACCESSORIES. NO FURTHER INVESTIGATION REQUIRED. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED AS THERE WAS NO ISSUE REPORTED FOR THE DEVICE PERFORMANCE OR QUALITY. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. OSCOR WILL CONTINUE TO MONITOR THIS EVENT TYPE AND RISK. NO FURTHER FOLLOW-UP IS REQUIRED. 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.

    Additional Manufacturer Narrative · 0

    THE USER DID NOT IMPLANT THE ADAPTOR. THE PHYSICIAN WAS AN ATTEMPT TO IMPLANT THE ADAPTOR. HOWEVER, THE ADAPTOR WAS NOT NEEDED AS TWO NEW LEADS WERE IMPLANTED. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ADAPTOR UNIV2551 WAS UNABLE TO USE DURING THE PROCEDURE DUE TO UNKNOWN REASON. ADAPTOR UNIV2551 WAS AN ATTEMPTED IMPLANT. THERE WAS SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING DIFFERENT LEADS AND ACCESSORIES. THERE WAS SURGICAL INTERVENTION REPORTED BUT PATIENT OUTCOME IS UNHARMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869833 LEAD ADAPTOR PACEMAKER LEAD ADAPTOR DTD OSCOR INC C/IS-10 SS2 C1-17908 00885672008277

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Unknown Required Intervention