BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA DP PEDIATRIC BURR HOLE SYSTEM

    MDR report key: 5156947 · Received October 16, 2015

    Report

    Report Number
    9612007-2015-00019
    Event Type
    Malfunction
    Date Received
    October 16, 2015
    Report Date
    September 23, 2015
    Manufacturer
    INTEGRA NEUROSCICENCS IMPLANTS SA
    Product Code
    JXG
    PMA / PMN Number
    K861377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 11/16/2015. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE; REVIEW OF DEVICE HISTORY RECORDS; REVIEW OF COMPLAINTS HISTORY. RESULTS: THE COMPLAINT WAS REPORTED FOR AN INTEGRA DP VALVE (B)(4), LOT 190535. THE RECEIVED PRODUCT WAS AN UNOPENED BOX OF REF (B)(4), LOT 191445. THE RECEIVED VALVE WAS PRESSURE/FLOW TESTED AND FOUND WITHIN OPERATING PRESSURE SPECIFICATIONS. THE DEVICE HISTORY RECORDS OF THE INTEGRA DP VALVE SYSTEMS REF (B)(4) LOTS 190535 AND 191445 WERE REVIEWED. NO ANOMALY WAS DETECTED. THE BATCHES WERE RELEASED RESPECTIVELY IN APRIL AND JULY 2015 AND INCLUDED A TOTAL OF (B)(4) VALVES. NO SIMILAR COMPLAINTS WERE REPORTED FOR A PRODUCT FROM THESE BATCHES. THE INTEGRA COMPLAINT DATABASE FOR THE INTEGRA DP VALVE SYSTEMS WAS REVIEWED FOR THE LAST 3 YEARS. THE REVIEW INDICATED THE RATE OF COMPLAINT REPORTS FOR VALVE TESTING FAILURE PRIOR TO IMPLANT IS 0.1%. CONCLUSION: THE COMPLAINT IS NOT VERIFIED ON THE RECEIVED DEVICE WHICH WAS TESTED WITHIN SPECIFICATIONS. AS THE RECEIVED DEVICE IS NOT THE ACTUAL INVOLVED FAILED DEVICE, THE EXACT CAUSE OF THE REPORTED VALVE TESTING FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN USE WITH THE PATIENT, THE VALVE FAILED TO READ THE CORRECT PRESSURE AND THE DOCTOR HAD TO GO TO A BACKUP. NO OTHER INFORMATION WAS PROVIDED. SEVERAL REQUESTS FOR ADDITIONAL INFORMATION HAS BEEN MADE BUT TO DATE, NO NEW INFORMATION HAS BEEN RECEIVED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687462 INTEGRA DP PEDIATRIC BURR HOLE SYSTEM DP VALVE JXG INTEGRA NEUROSCICENCS IMPLANTS SA 190535

    Patients

    Seq Age Sex Outcome Treatment
    1