BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICROSENSOR VENTRICULAR CATHETER KIT

    MDR report key: 9182581 · Received October 11, 2019

    Report

    Report Number
    1226348-2019-00464
    Event Type
    Death
    Date Received
    October 11, 2019
    Report Date
    October 3, 2019
    Manufacturer
    RAYNHAM
    Product Code
    GWM
    PMA / PMN Number
    K153347
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED SINCE NO SAMPLE WAS RETURNED. DHR COULD NOT BE REVIEWED SINCE LOT NUMBER OR SERIAL NUMBER FOR COMPLAINT SAMPLE WAS NOT PROVIDED. THE COMPLAINT REPORTED WAS NOT CONFIRMED. 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 (B)(6), NJ TO (B)(6), 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

    (B)(4). THE COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND NO LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. THIS COMPLAINT WILL BE CLOSED AS 'NO COMPLAINT SAMPLE RETURNED TO CODMAN FOR EVALUATION'. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. (B)(4).

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS COMPLAINT IS ASSOCIATED WITH MEDWATCH 1226348-2019-00447.

    Description of Event or Problem · 1

    N/A.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOSPITAL CONTACTED THE INTEGRA ACCOUNT MANAGER TO STATE PATIENT DIED NIGHT OF (B)(6) 2019; THE INTEGRA ACCOUNT MANAGER WAS INFORMED THAT THE PATIENT DID UNDERGO ANOTHER SURGERY TO PLACE ANOTHER VENTRICULAR MICROSENSOR (SENSOR 3) IN THIS WEEK. THIS WAS DURING THE WEEK OF (B)(6) 2019, NO EXACT DATE PROVIDED. SENSOR 3 ALSO FAILED BUT NO FURTHER DETAILS WAS GIVEN AT ALL AROUND WHAT THE FAILURE WAS AS INFORMATION WAS UNKNOWN. NO OTHER INFORMATION IS KNOWN AT THIS STAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973678 MICROSENSOR VENTRICULAR CATHETER KIT ICP MICROSENSORS (ROHS) GWM RAYNHAM

    Patients

    Seq Age Sex Outcome Treatment
    1 Death