BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3173681 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10485
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 29, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A CATHETER FRACTURED IN THE SPINE, BACK IN (B)(6) 2012 AND EXPERIENCED "SEVERE WITHDRAWAL". IT WAS INDICATED THAT ¿PATIENT¿S LEGS USUALLY COULD NOT MOVE AT ALL BUT WHEN PATIENT WAS IN WITHDRAWAL INDIVIDUALS COULD NOT HOLD DOWN LEGS AT ALL¿. IT WAS ADDED THAT PATIENT DESCRIBED THE LEGS AS "FLYING ALL OVER THE PLACE¿. IT WAS NOTED THAT PATIENT HEALTHCARE PROVIDER (HCP) COULD NOT FIGURE OUT CATHETER HAD "CRACKED". IT WAS REPORTED THAT CATHETER WAS REVISED AND PATIENT WAS ABLE TO RESUME THERAPY. THE CATHETER WAS REPLACED ON (B)(6) 2012 BUT COULD NOT VERIFY THE DATE. THE PUMP WAS BEING USED TO DELIVER BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273727 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Other| R