BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZY PERMANENT PACING LEAD

    MDR report key: 19405447 · Received May 28, 2024

    Report

    Report Number
    1035166-2024-00061
    Event Type
    Death
    Date Received
    May 28, 2024
    Report Date
    May 28, 2024
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    PMA / PMN Number
    K915008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED, HOWEVER, INSPECTION PROCEDURES REQUIRE ANY OSCOR PRODUCT TO PASS ALL IN-PROCESS AND QA FINAL INSPECTION BEFORE SHIPPING TO THE CUSTOMER. THE DEVICE WAS NOT RETURNED FOR EVALUATION; ALLEGATION RELATES TO NON-CAPTURE ON THE RIGHT ATRIAL (RA) LEAD. ONLINE OBITUARY NOTED PATIENT DECEASED (DATE UNKNOWN). THE COMPLAINT IS NON-VERIFIABLE AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. 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

    MEDWATCH # MW5154795: INTERFACE UPDATE, PATIENT STATUS UPDATED TO EXPIRED. ONLINE OBITUARY NOTED PATIENT DECEASED ON THE (B)(6) 2024. ALLEGATION RELATES TO NON-CAPTURE ON THE RIGHT ATRIAL (RA) LEAD ON THE PRESENTING ELECTROGRAMS (EMG) FOUR DAYS PRIOR PASSING. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652158 ZY PERMANENT PACING LEAD PERMANENT PACEMAKER ELECTRODE DTB OSCOR INC. ZY 52 JUSBV

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death