BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4023908 · Received August 20, 2014

    Report

    Report Number
    3004209178-2014-15586
    Event Type
    Injury
    Date Received
    August 20, 2014
    Date of Event
    July 29, 2014
    Report Date
    July 29, 2014
    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
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SPINAL SURGERY, THE CATHETER WAS SLICED/DAMAGED. THE CATHETER WAS BEING REVISED THE SAME DAY. THE DEVICE SYSTEM WAS DELIVERING GABLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    THE PATIENT HAD NO SYMPTOMS RELATED TO THE EVENT. THE LOCATION OF THE CATHETER DAMAGE WAS IN THE PROXIMAL/PUMP SEGMENT. A REVISION WAS DONE (B)(6) 2014. THE SURGEON CUT OFF A PIECE OF THE DAMAGED CATHETER AND REATTACHED THE PUMP SEGMENT TO THE SPINAL SEGMENT. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503299 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00013 YR Required Intervention