BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXION PERMANENT PACING LEAD

    MDR report key: 20337746 · Received September 30, 2024

    Report

    Report Number
    1035166-2024-00101
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 18, 2023
    Report Date
    September 30, 2024
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    PMA / PMN Number
    K964107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RIGHT VENTRICULAR LEAD REMAINS IN SERVICE FOR APPROXIMATELY 22 YEARS, 3 MONTHS SINCE THE SEPTEMBER 18, 2023, EVENT DATE. NO LEAD WAS RETURNED TO OSCOR INC. FOR EVALUATION, HOWEVER, A COMPLAINT NOTIFICATION WAS PROVIDED. BASED UPON THE IMPLANT DATE OF THIS LEAD ON (B)(6) 2021, THE DEVICE HISTORY RECORD IS BEYOND OSCOR'S RECORD RETENTION PERIOD. WITHOUT THE RETURN OF THE ACTUAL DEVICE IN QUESTION, FOR EVALUATION, OSCOR INC. IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. INSPECTION PROCEDURES REQUIRE ANY OSCOR PRODUCT TO PASS ALL IN-PROCESS AND QA FINAL INSPECTION BEFORE SHIPPING TO THE CUSTOMER. THIS COMPLAINT IS NON-VERIFIABLE AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. IN CONCLUSION, BASED ON THE INFORMATION AVAILABLE AT THIS TIME IT CANNOT BE CONFIRMED THAT THE PRODUCT FAILED TO MEET REQUIREMENTS. 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

    PATIENT CONTACTED CLINIC AND SAID THEIR DEVICE ISN'T WORKING AND NOW IT HAS ALSO STARTED VIBRATING. SENT IN A REMOTE TODAY AND EVERYTHING LOOKS FINE. CAN OUR DEVICES VIBRATE? TECHNICAL SERVICE ASSESSMENT: DISCUSSED WITH CALLER THAT OUR DEVICE CANNOT VIBRATE. ASKED ABOUT WHEN PATIENT MENTIONED THEY STARTED TO FEEL THIS AND FEELINGS, THEY SAID OVER PAST FEW WEEKS. DISCUSSED RAAT IS ON AND SOMETIMES PATIENT'S FEEL THAT, BUT IT HAS BEEN ON FOR SOME TIME, SO THIS IS NOT NEW. NO PATIENT HEALTH CONSEQUENCES OR IMPACT. EVENTED ONLY BECAUSE OF PATIENT ALLEGATION OF THEIR DEVICE NOT WORKING. NOTHING MENTIONED WITH THIS ALLEGATION. ADDITIONAL INFORMATION 12/SEP/2024, THE EVENT DATE FOR THIS CASE WAS ON 09/18/2023, HOWEVER THE AWARE DATE WAS 08/27/2024, THAT IS WHY IT HAD NOT BEEN REPORTED TO YOU EARLY. IT WAS REPORTED THAT THIS RIGHT VENTRICULAR LEAD TRIGGERED A LEAD SAFETY SWITCH DUE TO LOW PACING IMPEDANCE, MEASURING BELOW 200 OHMS. IT WAS OBSERVED THAT THE IMPEDANCE HAD BEEN GRADUALLY DECREASING OVER THE PAST FIVE MONTHS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RIGHT VENTRICULAR LEAD REMAINS IN SERVICE FOR APPROXIMATELY 22 YEARS, 3 MONTHS. PATIENT INITIALS ARE (B)(6); NO PICTURES, IMAGES, OR VIDEOS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915733 FLEXION PERMANENT PACING LEAD PERMANENT PACEMAKER ELECTRODE DTB OSCOR INC. 4017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown