BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE IN CARTRIDGE, 5MM

    MDR report key: 10914342 · Received November 27, 2020

    Report

    Report Number
    3004450998-2020-00039
    Event Type
    Injury
    Date Received
    November 27, 2020
    Date of Event
    September 24, 2020
    Report Date
    November 27, 2020
    Product Code
    NJK
    UDI-DI
    00896506002286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPIRATION VALVE MODEL NUMBER(S), THE TOTAL NUMBER OF DEVICES PLACED AND THE TREATMENT INDICATION COULD NOT BE DETERMINED. ATTEMPTS WERE MADE TO OBTAIN HEALTHCARE PROVIDER INFORMATION IN ORDER TO INVESTIGATE THE PATIENT REPORTED EVENT; HOWEVER, NO HEALTHCARE PROVIDER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    PATIENT CONTACTED GYRUS ACMI, INC. ONE MONTH AFTER PLACEMENT OF SPIRATION VALVE(S). PATIENT INDICATED HE EXPERIENCED POST-PROCEDURAL COMPLICATIONS AND WAS HOSPITALIZED FOR TWELVE DAYS. AFTER DISCHARGE FROM HOSPITAL HE INDICATED THAT HE WAS EXPERIENCING WEAKENING OF LEGS, SHORTNESS OF BREATH, REQUIRING HIM TO SIT DOWN TO CATCH HIS BREATH AFTER WALKING. PATIENT INDICATED HE HAD CONTACTED HIS PHYSICIAN AND WAS ADVISED TO GO TO THE EMERGENCY ROOM. NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1379998 VALVE IN CARTRIDGE, 5MM SPIRATION VALVE 5MM NJK SVS-V5-00 UNKNOWN 00896506002286

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O