BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2955041 · Received February 11, 2013

    Report

    Report Number
    3007566237-2013-00443
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    January 23, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE DAY OF THIS REPORT PATIENT WENT TO THE CLINIC WITH A FEVER. THE PATIENT/RELATIVES TOLD THE PHYSICIAN THEY ASSUMED A "PUMP MALFUNCTION" HAD OCCURRED. BECAUSE THE PATIENT HAD A FEVER, BUT NO WORSENING SYMPTOMS, HE WAS NOT HOSPITALIZED. IT WAS ADDED THAT THE ATTENDING PHYSICIAN HAD NO FURTHER INFORMATION REGARDING THE PUMP. DRUG DELIVERED VIA THE DEVICE WAS BACLOFEN AT A DAILY DOSE OF 625MCG. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAUSE OF THE PATIENTS FEVER WAS UNKNOWN. IT WAS UNKNOWN IF IT WAS RELATED TO THE PATIENT'S PUMP OR ITB THERAPY. THE PATIENT OUTCOME WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58279 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR