BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIS/IS-15

    MDR report key: 19119148 · Received April 16, 2024

    Report

    Report Number
    1035166-2024-00028
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    November 15, 2023
    Report Date
    May 9, 2024
    Manufacturer
    OSCOR INC.
    Product Code
    DTD
    UDI-DI
    00836559002680
    PMA / PMN Number
    K925168
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED TO OSCOR INC. FOR EVALUATION AS CUSTOMER STATED THE DEVICE IS STILL IN USE; HOWEVER, A COMPLAINT NOTIFICATION WAS PROVIDED. WITHOUT THE RETURN OF THE ACTUAL DEVICE IN QUESTION FOR EVALUATION, OSCOR INC. IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT. THE LACK OF LOT TRACEABILITY PREVENTS PERFORMING A DEVICE HISTORY RECORDS REVIEW FOR ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. THE REPORTED ISSUE OF THRESHOLD CANNOT BE CONFIRMED BY PHOTOS PROVIDED. A REVIEW OF THE MANUFACTURING PROCESSES INDICATES THE PRODUCTION OPERATORS ARE INSTRUCTED TO 100% VISUALLY INSPECT FOR ANY OBVIOUS DEFECT PRIOR TO SHIPMENT. SEVERAL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL PATIENT AND EVENT INFORMATION, AND ALL ATTEMPTS WITH ADDITIONAL DETAILS PROVIDED ARE CONTAINED IN THE ATTACHMENTS UNDER THE DILIGENCE LOG. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED AS THE DEVICE IS STILL IN USE. 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.

    Additional Manufacturer Narrative · 0

    H2: THE CUSTOMER STATED THE DEVICE WAS EXPLANTED AND DISCARDED ON (B)(6) 2023. 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 APPROXIMATELY FOUR WEEKS POST IMPLANT THAT BOTH EPICARDIAL RIGHT VENTRICULAR (RV) LEADS EXHIBITED HIGH THRESHOLDS AND BLOOD INSIDE THE LEADS. THE EPICARDIAL RV LEADS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PRODUCT WAS USED FOR AN EPICARDIAL PACEMAKER IMPLANTATION. THEN, THE SECOND PROCEDURE WAS A REVISION/ADDITION OF NEW EPICARDIAL ELECTRODES DUE TO HIGH THRESHOLDS ON THE LEADS. IT IS UNKNOWN WHICH LEADS THE ADAPTOR WAS ATTACHED TO. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. BLOOD WAS FOUND IN LEADS UPON EXPOSURE DURING REVISION PROCEDURE- ASSUMED BLOOD IN LEADS FROM USE IN BODY. THERE WAS NO BLOOD LOSS ASSOCIATED WITH BLOOD IN THE LEADS. NO LEAKAGE OBSERVED DURING PROCEDURE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 04/28/2024: THE CUSTOMER STATED THE DEVICE WAS EXPLANTED AND DISCARDED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340999 BIS/IS-15 PACEMAKER LEAD ADAPTOR DTD OSCOR INC. BIS/IS-15 00836559002680

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention