BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS VALVE

    MDR report key: 17029328 · Received May 31, 2023

    Report

    Report Number
    3001587388-2018-18215
    Event Type
    Malfunction
    Date Received
    May 31, 2023
    Date of Event
    April 12, 2018
    Report Date
    June 4, 2018
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE ARE RE-SUBMITTING THIS REPORT PER THE FOLLOWING REQUEST BY FDA: 3001487388-2018-18215 - 1. INCORRECT CFN NUMBER RESUBMIT AS 3001587388-2018-18215 - 1 MISSING INITIAL REPORT.

    Additional Manufacturer Narrative · 0

    WE ARE RE-SUBMITTING THIS REPORT PER THE FOLLOWING REQUEST BY FDA: 3001487388-2018-18215 - 1 INCORRECT CFN NUMBER RESUBMIT AS 3001587388-2018-18215 - 1 MISSING INITIAL REPORT.

    Description of Event or Problem · 0

    THE PHYSICIAN INFORMS US THAT THE PATIENT HAS BEEN IMPLANTED WITH AN ADJUSTABLE VALVE INCLUDING AN ANTI-SIPHON IN (B)(6) 2017. THE IMPLANTATION OF THE VALVE WAS IN THE PECTORAL REGION. ON (B)(6) 2018, HYDROCEPHALUS SYMPTOMS WAS OBSERVED ON THE PATIENT, AND THE PHYSICIAN USED THE CONTRAST MEDIUM TO VERIFY THE CSF DRAINAGE: THE CONTRAST MEDIUM DID NOT FLOW TO DISTAL SIDE OF THE VALVE. THE VALVE HAS BEEN EXPLANTED. FOR ADDITIONAL INFORMATION, THE PHYSICIAN SENT THE X-RAY IMAGE AND WE FIND THAT THE POSITIONING OF THE ANTI-SIPHON BALL ENCOURAGES US TO SUSPECT A SLIGHTLY TITLED POSITION. THIS COULD EXPLAIN THE INCIDENT.

    Description of Event or Problem · 0

    THE PHYSICIAN INFORMS US THAT THE PATIENT HAS BEEN IMPLANTED WITH AN ADJUSTABLE VALVE INCLUDING AN ANTI-SIPHON IN (B)(6) 2017. THE IMPLANTATION OF THE VALVE WAS IN THE PECTORAL REGION. ON (B)(6) 2018, HYDROCEPHALUS SYMPTOMS WAS OBSERVED ON THE PATIENT, AND THE PHYSICIAN USED THE CONSTRAST MEDIUM TO VERIFY THE CSF DRAINAGE : THE CONTRAST MEDIUM DID NOT FLOW TO DISTAL SIDE OF THE VALVE. THE VALVE HAS BEEN EXPLANTED. FOR ADDITIONAL INFORMATION, THE PHYSICIAN SENT THE X-RAY IMAGE AND WE FIND THAT THE POSITIONING OF THE ANTI-SIPHON BALL ENCOURAGES US TO SUSPECT A SLIGHTLY TITLED POSITION. THIS COULD EXPLAIN THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1837536 POLARIS VALVE POLARIS ADJUSTABLE VALVE JXG SOPHYSA SPV-SX D0367

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention