BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAVITY COMPENSATING ACCESSORY,MEDIUM

    MDR report key: 6238512 · Received January 10, 2017

    Report

    Report Number
    9612007-2017-00002
    Event Type
    Injury
    Date Received
    January 10, 2017
    Date of Event
    September 14, 2016
    Report Date
    December 20, 2016
    Manufacturer
    INTEGRA NEUROSCICENCS IMPLANTS SA
    Product Code
    JXG
    PMA / PMN Number
    K152897
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED 3/01/2017. METHOD: -DHR REVIEW, -TREND ANALYSIS, - FAILURE ANALYSIS. THE DEVICE HISTORY RECORDS REVIEW OF THE GCA REF 903435, LOT 193322 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. A REVIEW OF INTEGRA COMPLAINT TRACKING DATABASE SINCE JANUARY 2014 REVEALED NO OTHER COMPLAINT. NO TREND IS OBSERVED VISUAL INSPECTION UNDER MAGNIFICATION OF THE GRAVITY COMPENSATING ACCESSORY (GCA) REVEALED NO ANOMALY THAT COULD EXPLAIN THE REPORTED BLOCKAGE. THE GCA WAS PRESSURE/FLOW TESTED IN BOTH HORIZONTAL AND VERTICAL POSITIONS AND FOUND WITHIN SPECIFICATIONS. THE COMPLAINT IS NOT VERIFIED ON THE RECEIVED GCA, THE DEVICE INVESTIGATION DOES NOT ALLOW TO EXPLAIN THE REPORTED OBSTRUCTION. CONCLUSION: THE GCA IS IMPLANTED IN SERIES WITH A HYDROCEPHALUS VALVE TO CONTROL CEREBROSPINAL FLUID DRAINAGE FROM THE CEREBRAL VENTRICLES TO AN APPROPRIATE DRAINAGE SITE. THE GCA IS DESIGNED TO COUNTERBALANCE GRAVITY¿S EFFECTS ON THE FLUID COLUMN WITHIN THE OUT¬FLOW (DRAINAGE) CATHETER OF AN IMPLANTED SHUNT SYSTEM. THE REPORTED INSUFFICIENT DRAINAGE, A FEW WEEKS AFTER IMPLANTATION, IS LINKED TO THE SYSTEM (VALVE + GCA) AND MAY BE RELATED TO SEVERAL REASONS: AS THE GCA WAS FOUND WITHIN SPECIFICATIONS, THE INSUFFICIENT DRAINAGE MAY BE LINKED TO THE VALVE MALFUNCTION (OR NOT SUITED TO THE PATIENT), OR TO THE CHOICE OF GCA OPERATING CHARACTERISTICS (TOO MUCH RESISTANCE ADDED). OBSTRUCTION OF THE HYDROCEPHALUS VALVE SYSTEM (WITH ANTIGRAVITY SYSTEM OR NOT) IS A KNOWN COMPLICATION OF VALVE THERAPY, AS INDICATED IN THE GCA INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    ON (B)(6) 2016 A (B)(6) FEMALE PATIENT HAD THE 903435 GRAVITY COMPENSATING ACCESSORY IMPLANTED ALONG WITH A FIXED PRESSURE VALVE. IN THE WEEKS FOLLOWING THIS SURGERY, SPECIFICALLY AROUND (B)(6) 2016 THE PATIENT WAS EXPERIENCING DIFFICULTY WITH HER GAIT AND A SCAN WAS PERFORMED. THE SCANNER DETECTED HYDROCEPHALUS, SUGGESTING THAT THE GRAVITY COMPENSATING ACCESSORY WAS NOT ALLOWING THE CEREBROSPINAL FLUID (CSF) TO DRAIN. TO SOLVE THIS SITUATION, IT WAS NECESSARY TO SURGICALLY REMOVE THE GRAVITY COMPENSATING ACCESSORY AND IMPLANT A PROGRAMMABLE VALVE. THIS TOOK PLACE ON (B)(6) 2016. THE PROGRAMMABLE VALVE WAS A POLARIS SPVA VALVE, MANUFACTURED BY SOPHYSA. THE HYDROCEPHALUS HAS BEEN STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20101 GRAVITY COMPENSATING ACCESSORY,MEDIUM ANTI-SIPHON DEVICE JXG INTEGRA NEUROSCICENCS IMPLANTS SA 0193322

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention