BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PY PERMANENT PACING LEAD

    MDR report key: 11901247 · Received May 28, 2021

    Report

    Report Number
    1035166-2021-00050
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    April 27, 2021
    Report Date
    July 14, 2021
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    PMA / PMN Number
    K862330
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP 1. B4, D4, G6, H2 & H10. ADDED THE ADDITIONAL SECTIONS TO INCLUDE THE MODEL NUMBER, CATALOG NUMBER AND EXPIRATION DATE. 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

    THE LEAD WAS USED FOR TREATMENT. THE LEAD WAS IN SERVICE FOR APPROXIMATELY 16 YEARS, 9 MONTHS BEFORE BEING EXPLANTED ON (B)(6) 2021. THE LEAD WAS EXPLANTED AND NOT RETURNED FOR ANALYSIS. NO ALLEGATION OUR DEVICE FAILED TO MEET ITS PERFORMANCE SPECIFICATIONS OR CAUSED OR CONTRIBUTED TO THE INFECTION. INFECTION IS A RECOGNIZED CLINICAL EVENT REFERENCED IN THE DEVICE'S LABELING AND/OR REPORTED IN THE MEDICAL LITERATURE. QA IS UNABLE TO REVIEW THE DEVICE HISTORY RECORD FOR THIS LEAD MODEL AS IT IS BEYOND OSCOR'S RECORD RETENTION PERIOD, HOWEVER, INSPECTION PROCEDURES REQUIRE ANY OSCOR PRODUCT TO PASS ALL IN-PROCESS AND QA FINAL INSPECTION BEFORE SHIPPING TO THE CUSTOMER. QUALITY ASSURANCE PROCEDURE FINAL LABELING/PACKAGING INSPECTION OF ALL PRODUCTS INDICATES THAT ALL LABELING AND PACKAGING WILL BE INSPECTED 100%. SHAKE THE OUTER TRAY BY HOLDING TAB OF OUTER TRAY TO ENSURE INNER TRAY IS LOOSE INSIDE THE OUTER TRAY. CHECK FOR FOREIGN MATERIAL AND TYVEK SEAL INTEGRITY. VERIFY THAT COLOR OF STERI-DOT CHANGED FROM BROWN TO GREEN. SEALED AREAS (TYVEK LID TO LIP OF TRAY) ARE CONTINUOUS AROUND ENTIRE PERIMETER OF TRAY. NO VOIDS, BREAKS, AND OR BUBBLES ALONG THE SEAL. THE ENTIRE SEAL SHOULD BE AT LEAST QUARTER INCH WIDE AND HAVE A FULL RIDGE. THE TYVEK PULL TAB MUST BE PROPERLY FOLDED INTO POSITION. EXAMINE THE SEAL AND BORDER FOR UNIFORMITY OF THE SEAL. CHECK FOR HOLES OR ANY OTHER DAMAGES THAT COULD VIOLATE STERILITY. THE INSTRUCTIONS FOR USE (IFU) INFORMS THE USER: THE LEADS ARE SUPPLIED STERILE. A STERILIZATION METHOD IS INDICATED ON THE PRODUCT LABEL. THE STERILITY IS COMPROMISED WHEN THE PACKAGE IS OPENED OR DAMAGED. OSCOR INC. DOES NOT ASSUME ANY LIABILITY OR RESPONSIBILITY FOR STERILIZATION BY A THIRD PARTY. IN ADDITION, THE IFU LISTS INFECTION AS AN ADVERSE EFFECT: INFECTION, LEAD MAY REQUIRE SURGICAL REMOVAL. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED. THIS LEAD IS NO LONGER MANUFACTURED BY OSCOR. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. OSCOR WILL CONTINUE TO MONITOR THIS EVENT TYPE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEADS WERE EXPLANTED DUE TO INFECTION. RECORDS INDICATE THE LEADS (REFINO 52 RU AND PY 48 PSBV) WERE IMPLANTED ON (B)(6) 2004 AND EXPLANTED ON (B)(6) 2021. THEY WERE SUBSEQUENTLY REPLACED ON (B)(6) 2021. REFERENCE (B)(4) FOR LEAD MODEL REFINO 52 RU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799914 PY PERMANENT PACING LEAD PERMANENT PACEMAKER ELECTRODE, PRODUCT CODE: DTB DTB OSCOR INC. PY 48 PSBV

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention