BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA DP PEDIATRIC BURR HOLE SYSTEM

    MDR report key: 5727996 · Received June 15, 2016

    Report

    Report Number
    9612007-2016-00013
    Event Type
    Malfunction
    Date Received
    June 15, 2016
    Date of Event
    May 25, 2016
    Report Date
    May 25, 2016
    Manufacturer
    INTEGRA NEUROSCICENCS IMPLANTS SA
    Product Code
    JXG
    PMA / PMN Number
    K152897
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 16 AUG 2016. THE PRODUCT WAS NOT RETURNED FOR EVALUATION THUS THE COMPLAINT IS UNVERIFIABLE. THE DEVICE HISTORY RECORDS OF REF 908142 LOT 0192731 WERE REVIEWED AND DID NOT REVEAL ANY ANOMALY. THE BATCH WAS MANUFACTURED IN DECEMBER 2015 AND INCLUDED (B)(4) PRODUCTS. NO SIMILAR COMPLAINT WAS RECEIVED FOR A PRODUCT FROM THIS BATCH. UPON REVIEW OF INTEGRA¿S COMPLAINT SYSTEM FROM JANUARY 2013 - JUNE 21, 2016, ONE (1) SIMILAR COMPLAINT FOR AN INTEGRA DP VALVE HAS BEEN REPORTED. NO TREND IS OBSERVED. CONCLUSION: WITHOUT ACTUAL DEVICE TO INVESTIGATE, THE ROOT CAUSE OF THE REPORTED PROBLEM OF FLUSH COULD NOT BE DETERMINED. NO FURTHER INVESTIGATION NOR CORRECTIVE ACTION IS DEEMED REQUIRED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 10 OCT 2016. THE INVESTIGATION INCLUDED: METHODS: -EVALUATION OF ACTUAL DEVICE, -REVIEW OF DEVICE HISTORY RECORDS, -REVIEW OF COMPLAINT HISTORY. RESULTS: EVALUATION OF DEVICE: THE VALVE WAS BLOCKED, NO FLUSH WITH WATER WAS POSSIBLE. AIR ASPIRATION USING A SYRINGE INITIALLY SHOWED RESISTANCE, THEN RESISTANCE DISAPPEARED AND THE VALVE WAS UNBLOCKED. AFTER DECONTAMINATION, THE VALVE WAS PRESSURE/FLOW TESTED AND FOUND WITHIN SPECIFICATIONS. THE COMPLAINT IS VERIFIED, THE RECEIVED VALVE COULD NOT BE FLUSHED. THE DEVICE HISTORY RECORDS OF REF 908142 LOT 0192731 WERE REVIEWED AND DID NOT REVEAL ANY ANOMALY. DEVICE HISTORY RECORDS OF THIS VALVE SN (B)(4) SHOWED THIS VALVE WAS TESTED WITHIN SPECIFICATIONS AT TIME OF MANUFACTURING. THE BATCH WAS MANUFACTURED IN DECEMBER 2015 AND INCLUDED 21 PRODUCTS. NO SIMILAR COMPLAINT WAS RECEIVED FOR A PRODUCT FROM THIS BATCH UPON REVIEW OF INTEGRA¿S COMPLAINT SYSTEM FROM JANUARY 2013 - JUNE 21, 2016, ONE (1) SIMILAR COMPLAINT FOR AN INTEGRA DP VALVE HAS BEEN REPORTED ((B)(4) IN JANUARY 2015). NO TREND IS OBSERVED. CONCLUSION: THE VALVE INVESTIGATION COULD NOT DETERMINE THE EXACT CAUSE OF THE BLOCKAGE. IT IS POSSIBLE THAT SOME DEBRIS RELEASED DURING IMPLANTATION PROCEDURE WAS BLOCKING THE VALVE MECHANISM. THE COMPLAINT RATE FOR SUCH EVENT IS LOW ((B)(4)) AND THE INTEGRA DP VALVES ARE MARKETED SINCE OVER 30 YEARS: NO FURTHER INVESTIGATION NOR CORRECTIVE ACTION IS DEEMED REQUIRED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FOR THE 908142 DP PEDIATRIC BURR HOLE SYSTEM. ON (B)(6) 2016, A (B)(6) FEMALE PATIENT, WAS UNDERGOING A VP SHUNT PLACEMENT WITH STEALTH FOR HYDROCEPHALUS. SHE DID NOT SUSTAIN ANY INJURY AND HAD A GOOD OUTCOME. THE REPORT STATED THAT AFTER THE SHUNT WAS PLACED AND CONNECTED TO THE VENTRICULAR CATHETER, THE SYSTEM WOULD NOT FLUSH PER THE NORMAL PROCESS. ACCORDING TO THE SURGEON, IT APPEARED THAT THE VALVE WAS NOT WORKING PROPERLY. A NEW SYSTEM WAS CONNECTED TO THE EXISTING VENTRICULAR CATHETER AND THE SYSTEM WORKED FINE. THE INCIDENT DELAYED SURGERY BY 20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382667 INTEGRA DP PEDIATRIC BURR HOLE SYSTEM DP VALVE JXG INTEGRA NEUROSCICENCS IMPLANTS SA 0192731

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR