BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 3952564 · Received July 23, 2014

    Report

    Report Number
    3007566237-2014-02055
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    July 11, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PIRES J, FERREIRA A, AGUNDEZ M, CAMPOS I. COMPLICATIONS OF INTRATHECAL BACLOFEN PUMP: A CASE REPORT. ANNALS OF PHYSICAL AND REHABILITATION MEDICINE. 2014. SUMMARY/REPORTED EVENTS: CASE NUMBER PHHY2014PT086248, IS AN INITIAL LITERATURE REPORT RECEIVED ON 11 JUL 2014. THE AUTHORS DISCUSSED ABOUT A CASE REPORT OF COMPLICATIONS OF INTRATHECAL BACLOFEN PUMP. THIS REPORT REFERS TO A (B)(6) MALE PATIENT, WITH SPASTIC PARAPLEGIA DUE TO D4 ASIA A SPINAL CORD INJURY AND RIGHT UPPER BRACHIAL PLEXUS LESION, WITH A DOUBLE BARREL COLOSTOMY TO HEAL A PERINEAL PRESSURE SORE, PRESENTED AN ABDOMINAL WOUND DEHISCENCE WITH PARTIAL EXPOSURE OF THE INTRATHECAL BACLOFEN (UNKNOWN MANUFACTURER) PUMP AT A DOSE OF 350MUG/DAY, CONTINUOUS, ASSOCIATED WITH SIGNS AND SYMPTOMS OF ACUTE BACLOFEN WITHDRAWAL, AND EVENTUAL SEPSIS. AS A RESULT, THE PATIENT UNDERWENT REMOVAL OF THE BACLOFEN INFUSION SYSTEM, CLOSURE WITH PLASTIC SKIN SURGERY, AND PLACEMENT OF A NEW INTRATHECAL BACLOFEN (ITB) INFUSION SYSTEM (SYNCHROMED II, MEDTRONIC), WITH THE PUMP PLACED IN THE RIGHT ABDOMINAL REGION. AUTHORS CONCLUDED THAT PATIENTS WITH BACLOFEN PUMPS REQUIRE PERIODIC MONITORING, NOT ONLY BY THE NEED TO FILL THE PUMP, BUT ALSO TO ASSESS THE RISK OF COMPLICATIONS RELATED TO DOSING OR MECHANICAL IMPLANT DYSFUNCTION, WHICH CAN BE SERIOUS AND LIFE-THREATENING. IT IS IMPORTANT TO INFORM PATIENTS ABOUT POSSIBLE RISKS AND COMPLICATIONS OF THIS DEVICE IN ORDER TO BE AWARE OF WARNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431903 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Life Threatening| R