BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHUNT TUNNELER

    MDR report key: 5961072 · Received September 19, 2016

    Report

    Report Number
    9612007-2016-00034
    Event Type
    Malfunction
    Date Received
    September 19, 2016
    Date of Event
    August 18, 2016
    Report Date
    September 1, 2016
    Manufacturer
    INTEGRA NEUROSCICENCS IMPLANTS SA
    Product Code
    JXG
    PMA / PMN Number
    K932273
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 27 OCT 2016. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINT HISTORY. RESULTS: THE TUNNELER WAS RECEIVED BENT, THE COMPLAINT IS VERIFIED. THE DEVICE HISTORY RECORDS OF REF 990001, LOT 193320 WERE REVIEWED AND DID NOT REVEAL ANY ANOMALY. THE BATCH WAS MANUFACTURED IN JANUARY 2016 AND INCLUDED (B)(4) PRODUCTS. NO SIMILAR COMPLAINT WAS RECEIVED FOR A PRODUCT FROM THIS BATCH. TUNNELER LOT 193320 WAS MANUFACTURED USING TUBING LOTS 193091 ((B)(4) PIECES), AND LOT 193230 ((B)(4) PIECES). BOTH LOTS USED THE SAME STAINLESS STEEL TUBING LOT 3021748. THE INTEGRA COMPLAINT TRACKING DATABASE FOR THE MALLEABLE TUNNELER REF 990001 WAS REVIEWED SINCE JANUARY 2013: NO SIMILAR COMPLAINT WAS RECEIVED. AROUND (B)(4) TUNNELERS BEEN SOLD FROM JANUARY 1, 2013 TO AUGUST 30, 2016 RESULTING IN A COMPLAINT OCCURRENCE RATE OF (B)(4). THE SINGLE COMPLAINT RECEIVED IN 2016 IS NOT CONSIDERED AS A NEGATIVE TREND. CONCLUSION: THE COMPLAINT IS VERIFIED. THE EXACT ROOT CAUSE OF THE BENT TUNNELER COULD NOT BE DETERMINED BY THE INVESTIGATION. GIVEN THE ABSENCE OF SIMILAR EVENTS AND GIVEN THE MANUFACTURING CONTROLS IN PLACE, NO FURTHER INVESTIGATION NOR CORRECTIVE ACTION IS DEEMED REQUIRED.

    Description of Event or Problem · 1

    THE 990001 TUNNELLER WAS REPORTED TO BE TOO SOFT AS IT WAS BENDING DURING INSERTION. THE DEVICE WAS IN CONTACT WITH PATIENT, ON (B)(6) 2016, BUT THERE WAS NO PATIENT INJURY. THE EVENT LED TO A 1 (ONE) HOUR INCREASE IN SURGERY TIME. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611411 SHUNT TUNNELER VALVE ACCESSORIES JXG INTEGRA NEUROSCICENCS IMPLANTS SA 193320

    Patients

    Seq Age Sex Outcome Treatment
    1