BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 4101849 · Received September 19, 2014

    Report

    Report Number
    1226348-2014-11986
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    September 8, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    PK914479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED MICROSENSOR P/N 82-6631; LOT # CRCDJB WAS DISCARDED BY THE CUSTOMER. EVALUATION WAS PERFORMED BASED ON THE PHOTO RECEIVED AND THE DEVICE HISTORY RECORDS REVIEW. BASED ON THE PHOTO RECEIVED, IT WAS CONFIRMED THAT THE DEVICE'S CATHETER IS SEVERELY BENT AT APPROXIMATELY 3CM FROM THE MICROSENSOR CASE. HOWEVER, IT IS NOT POSSIBLE TO CONFIRM THAT THE DEVICE'S CATHETER IS CRACKED. IT APPEARS THAT THE DEVICE WAS INADVERTENTLY BENT/DAMAGED BY THE CUSTOMER DURING USE. A LOT HISTORY RECORDS REVIEW FOR P/N 82-6631; LOT # CRCDJB WAS CONDUCTED AND IT WAS VERIFIED THAT ALL PRODUCTS IN THIS LOT NUMBER WERE CONFORMING TO THE REQUIRED SPECIFICATIONS WHEN RELEASED TO STOCK ON APRIL 08, 2014. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED, A REVIEW OF THE MANUFACTURING RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    E-MAIL RECEIVED FROM THE SALES REP. INFORMED THAT: "DURING THE PLACEMENT OF THE MICROSENSOR, THE MICROSENSOR OUTER COVERING CRACKED WHEN BENT AT 3CM (FROM THE TIP). THERE WAS NOT A 30 MINUTE DELAY IN THE PROCEDURE. SURGEON GOT A NEW MICROSENSOR AND IMPLANTED". DEVICE WAS DISCARDED BY THE HOSPITAL. ON (B)(6) 2014, ALTHOUGH ADDITIONAL QUESTIONS HAVE BEEN ASKED, IT APPEARS THE DEVICE MAY HAVE BEEN IMPLANTED INTO THE BRAIN AND THEN REMOVED. AS A RESULT, THE COMPLAINT WILL BE REPORTED AS A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582517 NEUROMONITOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. CRCDJB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention