BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN MICROSENSOR KIT WITH SKULL BOLT (EACH)

    MDR report key: 3143013 · Received June 3, 2013

    Report

    Report Number
    1226348-2013-18063
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 15, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    GWM
    PMA / PMN Number
    PK974088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THIS INVESTIGATION IT WAS NOTED THAT THE SUPPLIER PERFORMED THIS EVALUATION. DURING THE 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: 1 - SENSOR IS FUNCTIONAL. 2 - COSMETIC LIFTING OF SEALANT AT SENSOR. 3 - SEVERAL SEVERE KINKS ALONG CATHETER BODY. 4 - THE SENSOR PASSED ELECTRONIC, NOISE, LINEARITY/HYSTERESIS, AND SIGNAL DRIFT TESTS. MFG. DATE: 11/27/12. BASED ON THE ABOVE EVALUATION, SUPPLIER WAS UNABLE TO CONFIRM THE COMPLAINT. NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CLOSED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    REP REPORTED THAT THE MICROSENSOR WORKED FINE FOR THREE DAYS, HOWEVER, ON THE THIRD DAY IT STARTED GIVING NEGATIVE PRESSURE READINGS. PA REPLACED THE MICROSENSOR WITH ANOTHER ONE. PATIENT IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245608 CODMAN MICROSENSOR KIT WITH SKULL BOLT (EACH) DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1