BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4853499 · Received June 18, 2015

    Report

    Report Number
    3007566237-2015-01696
    Event Type
    Injury
    Date Received
    June 18, 2015
    Report Date
    May 29, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED WITHDRAWAL IN 2013 AND HAD A SIMILAR RESPONSE TO ¿BURNING BACK PAIN¿. THE PATIENT ALSO EXPERIENCED ITCHING AND INCREASED SPASTICITY. THE CAUSE OF THE BACK PAIN AND WITHDRAWAL SYMPTOMS PER THE PHYSICIANS INVOLVED WAS ¿BACLOFEN WITHDRAWAL¿. THE PUMP WAS VERY CLOSE TO END OF SERVICE (EOS) AND THE PUMP WAS REPLACED DUE TO NORMAL BATTERY DEPLETION ON (B)(6) 2013. IT WAS ASSUMED THERE WAS A CATHETER ISSUE AS THE 8780 REPLACED THE 8709 ON (B)(6) 2013, HOWEVER SPECIFICS WERE NOT KNOWN. THE WITHDRAWAL SYMPTOMS WENT AWAY RIGHT AFTER THE CATHETER WAS REPLACED. THE PUMP WAS BEING USED TO DELIVER INTRATHECAL BACLOFEN THERAPY. ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397141 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00018 YR Required Intervention