BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE CLYNDRICAL

    MDR report key: 10277733 · Received July 15, 2020

    Report

    Report Number
    1226348-2020-00036
    Event Type
    Injury
    Date Received
    July 15, 2020
    Date of Event
    January 9, 2020
    Report Date
    January 10, 2020
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K122118
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE HAKIM VALVE WAS RETURNED FOR EVALUATION: DHR - LOT CKGB76, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. MANUFACTURING DATE 06/02/2009. EXPIRATION DATE 05/31/2014. FAILURE ANALYSIS - THE VALVE PASSED THE TESTS FOR PROGRAMMING, OCCLUSION, LEAKS, REFLUX AND PRESSURE. NO ROOT CAUSE COULD BE DETERMINED, AS THE TECHNICIAN WAS UNABLE TO CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER. BETWEEN 05NOV2019 AND 30JUN2020, APPROXIMATELY 2,200 MDRS SUBMITTED ELECTRONICALLY BY INTEGRA LIFESCIENCES VIA TRACKWISE, INTEGRA'S COMPLAINT HANDLING SYSTEM, WERE NOT RECEIVED BY CDRH DUE TO A COMPUTER SYSTEM ISSUE. WITHIN THIS TIME PERIOD, AN ERROR WITH INTEGRA'S MIDDLEWARE, WHICH FACILITATES COMMUNICATIONS BETWEEN TRACKWISE AND THE FDA SYSTEM, CAUSED THE COMPLAINT RECORDS TO CLOSE AND INDICATE WE HAD RECEIVED AN ACKNOWLEDGEMENT 3 FROM THE FDA WHEN WE HAD NOT. INTEGRA INTERPRETED THE ACKNOWLEDGEMENT AS A SUCCESSFUL SUBMISSION; HOWEVER, SUBSEQUENT INVESTIGATION REVEALED THE ACKNOWLEDGEMENT 3 RECEIVED WAS FROM OUR MIDDLEWARE AND NOT FROM THE FDA (THESE ACKNOWLEDGEMENTS HAVE BEEN RETAINED AS PART OF THE DOCUMENTATION OF THE MDR). THE MALFUNCTION WAS RELATED TO THE RELOCATION OF THE TRACKWISE APPLICATION TO A NEW DATA CENTER DURING THE TRANSITION OF INTEGRA'S CORPORATE HEADQUARTERS FROM PLAINSBORO, NJ TO PRINCETON, NJ. PREVIOUSLY, INTEGRA HAD BEEN SUCCESSFULLY RECEIVING ACKNOWLEDGEMENTS 1, 2, AND 3 FROM THE FDA, AND OUR RECORDS REFLECT THESE ACKNOWLEDGEMENTS, INCLUDING THE DATE AND TIME STAMPS. CAPA PR 229048 AND NC 20-011 HAVE BEEN OPENED BY INTEGRA TO FURTHER INVESTIGATE THE NONCONFORMANCE AND DEVELOP A CORRECTIVE ACTION PLAN. THE MIDDLEWARE ERROR HAS BEEN CORRECTED, AND INTEGRA HAS FILED MDRS SINCE THE CORRECTION AND VERIFIED THAT THE APPROPRIATE ACKNOWLEDGEMENTS HAVE BEEN RECEIVED FROM THE FDA. INTEGRA IS RESUBMITTING ALL IMPACTED MDR REPORTS FOR THE TIME PERIOD 05NOV2019 THROUGH 30JUN2020. INTEGRA LIFESCIENCES CONTACTED (B)(6) , DIRECTOR OF REGULATORY PROGRAMS, OFFICE OF PRODUCT EVALUATION AND QUALITY AND (B)(6) , ASSISTANT DIRECTOR, MDR TEAM, OFFICE OF PRODUCT EVALUATION AND QUALITY ON JULY 8-9, 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AFTER THE HAKIM VALVE WAS IMPLANTED, THE PATIENT BECAME IMMOBILE, THE SURGEON SUSPECTED A SHUNT DYSFUNCTION AND DECIDED TO EXPLANT THE VALVE. A POSTOPERATIVE SCINTIGRAPHY SHOWED THERE WAS NO FLOW IN THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742140 PROG VALVE CLYNDRICAL CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1