BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1411877 · Received July 8, 2009

    Report

    Report Number
    3004209178-2009-04649
    Event Type
    Injury
    Date Received
    July 8, 2009
    Date of Event
    June 1, 2009
    Report Date
    June 10, 2009
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A COUPLE OF DAYS FOLLOWING THE PUMP REPLACEMENT, THE PATIENT EXPERIENCED INTERMITTENT WITHDRAWAL SYMPTOMS AND SPASTICITY. THE PATIENT WAS TREATED WITH UNSPECIFIED ORAL MEDICATION, A SINGLE BOLUS, AND AN INCREASE TO THE SIMPLE CONTINUOUS DOSE OVER THE LAST MONTH. DEVICE TROUBLESHOOTING INCLUDED X-RAYS, RE-OPENING THE POCKET TO CONFIRM THE CONNECTION, AND CATHETER ASPIRATION. THE HCP WENT IN TO REVISE THE CATHETER AND TEST THE SYSTEM; EVERYTHING TESTED FINE. GOOD FLOW WAS SEEN ON A DYE STUDY. THE PATIENT CONTINUED TO HAVE INTERMITTENT WITHDRAWAL/SPASTICITY. BOLUS DOSING WAS ADMINISTERED WITH SOME IMPROVEMENT; THEN THE SYMPTOMS OF WITHDRAWALS WOULD COME BACK. THE HCP CHANGED THE BACLOFEN SOLUTION; THERE WAS NO CHANGE IN WITHDRAWALS. PRIOR TO THE PUMP REPLACEMENT THE PUMP WAS PROGRAMMED TO 180 MCG/DAY. AT THE TIME OF THE REPORT, THE PUMP WAS PROGRAMMED TO 320 MCG/DAY WITH THE CONTINUING PROBLEM OF WITHDRAWALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention ACCESSORY: MODEL 8590-1| EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8578| PROGRAMMER: MODEL 8840| IMPLANTED:| CATHETER: MODEL 8709| IMPLANTED:| IMPLANTED:| EXPLANTED: