BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NPH LOW FLOW VALVE UNIT WITH RESERVOIR 15CM V CA

    MDR report key: 9121498 · Received September 25, 2019

    Report

    Report Number
    9612007-2019-00041
    Event Type
    Injury
    Date Received
    September 25, 2019
    Date of Event
    July 30, 2019
    Report Date
    September 4, 2019
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K140722
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - COMPLAINT STATED AN OSV II VALVE REF 909712 VALVE STOPPED WORKING 2 YEARS AFTER IMPLANTATION. THE RECEIVED VALVE WAS AN INTEGRA LOW FLOW VALVE REF 909512, LOT 197769, SERIAL NUMBER 945153. THE VALVE ONLY WAS RECEIVED, DISTAL CATHETER WAS CUT. PATENCY TESTING DID NOT REVEAL ANY ANOMALY. THE VALVE WAS PRESSURE/FLOW TESTED AND FOUND WITHIN SPECIFICATIONS. THE COMPLAINT IS NOT VERIFIED BY THE INVESTIGATION. THE EXACT CAUSE OF THE VALVE NOT WORKING AFTER 2 YEARS OF IMPLANTATION COULD NOT BE DETERMINED BY THE INVESTIGATION (NOTE: VENTRICULAR CATHETER WAS NOT RECEIVED). VALVE UNDERDRAINAGE IS A KNOWN COMPLICATION OF VALVE THERAPY, AS STATED IN THE DEVICE INSTRUCTIONS FOR USE. TRACEABILITY INFORMATION INITIALLY PROVIDED DID NOT MATCHED WITH THE RECEIVED PRODUCT. THE DEVICE HISTORY RECORDS OF REF 909512, LOT 197769, SN (B)(6) WERE REVIEWED AND DID NOT REVEAL ANY ANOMALY. DEVICE IDENTIFIER (B)(4). 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

    THE DEVICE WAS NOT YET RECEIVED BY THE MANUFACTURER FOR EVALUATION. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE 909712 OSVII CONNECTOR STOPPED WORKING ON (B)(6) 2019 AFTER TWO YEARS OF IMPLANTATION. THE FEMALE PATIENT DURING EVALUATION PRESENTED DROWSINESS AND APHASIA. THE PATIENT RECEIVED A NEW MEAN PRESSURE VALVE. ADDITIONAL INFORMATION WAS RECEIVED ON 17SEP2019 INDICTING THAT THE PATIENT WAS PREPPED FOR SURGERY, THERE WAS NO DELAY IN SURGERY NOTED AND THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914994 NPH LOW FLOW VALVE UNIT WITH RESERVOIR 15CM V CA NPH LOW FLOW VALVE JXG INTEGRA NEUROSCIENCES IMPLANTS S.A. 197769

    Patients

    Seq Age Sex Outcome Treatment
    1