BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3897118 · Received June 26, 2014

    Report

    Report Number
    3004209178-2014-12100
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    February 20, 2013
    Report Date
    June 6, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 85 90-1, LOT# N370643, IMPLANTED: 2014 (B)(6); PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT SINCE LAST IMPLANT. THE PATIENT WAS SCHEDULED TO HAVE A MAGNETIC RESONANCE IMAGING (MRI) SCAN ON (B)(6) 2014 AS SHE WAS HAVING ¿ISSUES¿ WITH HER IMPLANTED PUMP AND CATHETER. REPORTEDLY, THERE WERE ¿SOME ISSUES¿ WITH THE MEDICATION DELIVERY AND THE CATHETER. THE PATIENT WAS NOT HAVING RELIEF AND SHE REPORTED BAD SPASTICITY AND THE PAIN WAS UNMANAGED. THIS ISSUE HAD BEEN ¿ON AND OFF¿ SINCE IMPLANT. THE PATIENT DENIED FALLING. THIS DEVICE SYSTEM DELIVERED BACLOFEN AND GABAPENTIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374347 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR