BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 3792670 · Received May 6, 2014

    Report

    Report Number
    1226348-2014-11559
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    May 1, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    PK914479
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE SUPPLIER PERFORMED THIS EVALUATION. DURING EVALUATION A REVIEW OF THE QUALITY RECORDS WAS CONDUCTED AND PRIOR TO DISTRIBUTION THIS DEVICE MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS. THE CATHETER WAS EVALUATED AND THE FOLLOWING OBSERVATIONS NOTED: WIRES BROKEN INSIDE CATHETER. MULTIPLE SEVERE KINKS ALONG CATHETER BODY. SUTURES ATTACHED TO CATHETER MATERIAL. BLACK MARK (473) ON CONNECTOR. COSMETIC LIFTING OF SEALANT AT SENSOR. NO TESTING POSSIBLE. MFG DATE: 05/29/12. BASED ON THE ABOVE EVALUATION, IT APPEARS THAT THE DEVICE WAS INADVERTENTLY DAMAGED BY THE CUSTOMER DURING USE. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE DEVICE WAS IMPLANTED IN THE PATIENT. NO PROBLEM WAS NOTED. ON (B)(6), IT WAS NOTED THAT THE ICP EXPRESS WOULD NOT IDENTIFY THE SENSOR. THE DEVICE WAS EXPLANTED AND MONITORING DISCONTINUED. THE PATIENT'S CONDITION IS BEING MONITORED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270752 NEUROMONITOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR