BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESTREAM INTRASPINAL CAT KIT

    MDR report key: 3232912 · Received July 18, 2013

    Report

    Report Number
    1226348-2013-21348
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    LMP
    PMA / PMN Number
    PP890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 HAVE BEEN CONDUCTED AND THEY REVEALED THAT THE DEVICE CONFORMED TO ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO BEING RELEASED TO STOCK. IF AT SOME POINT, THE DEVICE IS RETURNED FOR EVALUATION THIS COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. BASED ON THIS EVALUATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CLOSED. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT WHEN THE DOCTOR WAS PULLING BACK ON THE CATHETER, HE COULD SEE THAT THE COIL INSIDE THE CATHETER BECAME ELONGATED AND WAS INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333954 SURESTREAM INTRASPINAL CAT KIT PORT & CATH, IMPLANTED, SUBCUT INTRASPINAL LMP CODMAN & SHURTLEFF, INC. 247042

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention