BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN IC MICROSENSOR

    MDR report key: 76960 · Received February 4, 1997

    Report

    Report Number
    76960
    Event Type
    Malfunction
    Date Received
    February 4, 1997
    Date of Event
    December 25, 1996
    Report Date
    January 7, 1997
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TRUMA PT HAD IC SENSOR INSERTED ON 12/23/96. HAND RESTRAINTS ORDERED AS PRECAUTION DURING ANESTHESIA RECOVERY RATHER THAN DUE TO PT HAVING HAD A VIOLENT BEHAVIOR HISTORY. AT 11 AM, WIRE NOTED TO BE BROKEN AT FARTHEST DISTANCE FROM PT. UNPLANNED RETURN TO SURGERY TO REPLACE SENSOR. NO POST-OP COMPLICATIONS. PT DISCHARGED TO RE-HAB 1/28/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN IC MICROSENSOR Implant INTRACRANIAL PRESSURE MICROSENSOR WIRE GWM JOHNSON & JOHNSON IC MICROSENSOR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other