BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMANENT PACING LEAD

    MDR report key: 18627771 · Received February 1, 2024

    Report

    Report Number
    1035166-2024-00003
    Event Type
    Injury
    Date Received
    February 1, 2024
    Report Date
    February 1, 2024
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    PMA / PMN Number
    K915008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS LEAD WAS USED IN TREATMENT. THE LEAD WAS EXPLANTED AND NOT RETURNED FOR ANALYSIS. SEVERAL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FOR PATIENT, SERIAL NUMBER, IMPLANT AND EXPLANT DATES, BUT WERE NOT SUCCESSFUL. THERE WAS NO SPECIFIC DEVICE PERFORMANCE FAILURE REPORTED, AND NO FURTHER INVESTIGATION IS REQUIRED. BASED UPON THE VOLUNTARY MDR REPORT#: (B)(4), IT WAS REPORTED THE INITIAL REPORTER WAS BOSTON SCIENTIFIC. HOWEVER, BASED UPON THEIR INVESTIGATION, THEY COULD NOT FIND WHERE THIS EVENT HAD BEEN REPORTED WITHIN THEIR COMPLAINT SYSTEM; THEREFORE THEY INITIATED A REPORT. NO FURTHER FOLLOW-UP IS REQUIRED. THE DEVICE WAS NOT RETURNED AND THERE WAS NO SPECIFIC DEVICE PERFORMANCE FAILURE REPORTED BY THE USER. THE EVENT WILL BE RE-EVALUATED 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 THIS RIGHT ATRIAL (RA) LEAD WAS EXPLANTED DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY THE FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B) (2), RECEIVED ON VOLUNTARY MDR REPORT#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1557631 PERMANENT PACING LEAD ZY PERMANENT PACEMAKER ELECTRODE DTB OSCOR INC. ZY52

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention