BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3902671 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-12276
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    July 12, 2010
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER; PRODUCT ID 8590-1, LOT# N253364, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REPORTED NO RELIEF FROM THE PUMP SINCE IMPLANT; THE PATIENT HAD LESS THAN 50% THERAPY RELIEF. REVISION SURGERY REVEALED THAT THE CATHETER WAS FRACTURED AT THE SPINOUS PROCESS AT THE SITE THAT IT EXITED FROM THE INTRATHECAL SPACE. THE DISTAL PIECE OF THE CATHETER REMAINED IN THE INTRATHECAL SPACE AS THE SURGEON COULD NOT SAFELY RETRIEVE IT. THE REST OF THE CATHETER WAS EXPLANTED. A NEW CATHETER, PUMP, AND POUCH WERE IMPLANTED. THE PATIENT STATUS WAS REPORTED AS ¿ALIVE-NO INJURY¿. THE DEVICE SYSTEM WAS DELIVERING HYDROMORPHONE, CLONIDINE AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380655 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00028 YR Required Intervention