BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3223436 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11671
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER INDICATED THE CATHETER MODEL AS 8731 WITH AN UNKNOWN SERIAL NUMBER, HOWEVER, PER MFR DEVICE REGISTRATION SYSTEM THE PATIENT HAD CATHETER MODEL: 8711 SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PROGRAMMER MODEL: 8835 SERIAL# (B)(4). (B)(4).

    Description of Event or Problem · 1

    A MIGRATION/DISLODGMENT OF DISTAL CATHETER SEGMENT WAS REPORTED. IT WAS STATED THAT THE PATIENT WAS NOT GETTING GOOD PAIN RELIEF. PER PHYSICIAN CATHETER WAS OUT OF INTRATHECAL SPACE AND WAS FOUND TO BE SO DURING REVISION SURGERY AS OF THE DATE OF THIS REPORT. THE CATHETER WAS REPLACED AND A NEW CATHETER WAS CONNECTED TO EXISTING PROXIMAL PIECE OF CATHETER. THE EXPLANTED CATHETER SEGMENT WAS DISCARDED. PATIENT STATUS AT TIME OF THIS REPORT WAS ¿NO INJURY/NO ADVERSE EVENT. DRUG DELIVERED VIA THE DEVICE WAS COMPOUNDED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322903 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention