BEUDAMED
    FDA Adverse Event Other Summary report: N

    STANDARD CUFF

    MDR report key: 105614 · Received July 16, 1997

    Report

    Report Number
    2648612-1997-00030
    Event Type
    Other
    Date Received
    July 16, 1997
    Date of Event
    June 11, 1997
    Report Date
    July 15, 1997
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE AND VALVE HOLDER HANDLE WERE NOT RETURNED TO ST. JUDE MEDICAL HEART VALVE DIVISION FOR EVALUATION. THE VALVE'S DEVICE HISTORY RECORD WAS EXAMINED TO ENSURE THAT EACH MFG AND INSPECTION OPERATION WAS FOLLOWED BY THE APPROPRIATE SIGNATURE AND DATE, INDICATING THAT THE PROCESS WAS PERFORMED IN ACCORDANCE WITH ST. JUDE MEDICAL'S SPECIFICATIONS. EACH OPERATION FOR THE MFG AND INSPECTION OF THIS VALVE AND ITS PACKAGING WAS FOLLOWED BY THE APPROPRIATE SIGNATURE AND DATE. INFO REVIEWED FROM THE VALVE'S DEVICE HISTORY RECORD INDICATED THE VALVE AND VALVE HOLDER HANDLE COMPLIED WITH ST. JUDE MEDICAL SPECIFICATIONS AT THE TIME OF MFR. RESULTS OF THIS INVESTIGATION REMAIN INCONCLUSIVE DUE TO THE FACT THE VALVE AND VALVE HOLDER HANDLE HAVE NOT BEEN RECEIVED AT ST. JUDE MEDICAL HEART VALVE DIVISION FOR EVALUATION. THE CAUSE OF THE VALVE HOLDER HANDLE BEING UNABLE TO SCREW ONTO THE VALVE REMAINS UNKNOWN.

    Description of Event or Problem · 1

    PER MEDWATCH FORM: PRIOR TO USE, IT WAS NOTED THAT THE VALVE WOULD NOT SCREW ONTO THE VALVE HOLDER HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD CUFF MECHANICAL HEART VALVE LWQ ST. JUDE MEDICAL PUERTO RICO, INC. 21A-101 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention