BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRA DP STANDARD VALVE SYSTEM

    MDR report key: 7906830 · Received September 25, 2018

    Report

    Report Number
    9612007-2018-00028
    Event Type
    Injury
    Date Received
    September 25, 2018
    Date of Event
    August 23, 2018
    Report Date
    September 6, 2018
    Manufacturer
    INTEGRA NEUROSCICENCS IMPLANTS SA
    Product Code
    JXG
    PMA / PMN Number
    K861377
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE INTEGRA DP VALVE WAS RECEIVED WITHOUT ITS PROXIMAL CATHETER, THE DISTAL CATHETER WAS RECEIVED SEPARATELY. DISTAL CATHETER WAS FRACTURED AT 2MM OF THE OVERMOLDING. THE DEVICE HISTORY RECORDS OF REF 901145, LOT 0171776 AND OF THE INVOLVED COMPONENTS (VALVE CHAMBER OUTLET AND DISTAL CATHETER) WERE REVIEWED AND DID NOT REVEAL ANY ANOMALY THAT COULD EXPLAIN THE REPORTED EVENT. THE DISTAL CATHETER WAS EXTRUDED AT INTEGRA NEUROSCIENCES IMPLANTS AND MANUFACTURING INCLUDES STRENGTH RESISTANCE TESTING: THE DISTAL CATHETER RESISTS TO 15 NEWTONS AND 600% OF ELONGATION. DEVICE HISTORY RECORDS CONFIRM RESISTANCE OF THE INVOLVED CATHETER COMPONENT WAS WITHIN SPECIFICATIONS. THE COMPLAINT IS VERIFIED, DISTAL CATHETER IS FRACTURED. THE EXACT ROOT CAUSE OF THE REPORTED FRACTURE AFTER OVER 3 YEARS OF IMPLANTATION COULD NOT BE DETERMINED BY THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE PHYSICIAN THAT THE 901145 INTEGRA DP STANDARD VALVE SYSTEM WAS EXPLANTED BECAUSE IT WAS BROKEN. COMPLEMENTARY INFORMATION WAS RECEIVED ON 07SEP2018 WITH THE FOLLOWING: THE PATIENT COMPLAINED OF MAJOR SWELLING IN THE NECK ON THE "TRAJECT" OF THE SHUNT. HE CONSULTED THE DEPARTMENT ON (B)(6) 2018. A DISCONNECTION OF THE CATHETER JUST DISTAL TO THE VALVE WAS SEEN ON THE X-RAY. ON (B)(6) 2018, A SURGICAL REVISION WAS PERFORMED. THE SYSTEM (EXCEPT THE VENTRICULAR CATHETER) WAS REMOVED AND A NEW STANDARD VALVE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745662 INTEGRA DP STANDARD VALVE SYSTEM DP VALVE JXG INTEGRA NEUROSCICENCS IMPLANTS SA 0000000171776

    Patients

    Seq Age Sex Outcome Treatment
    1