BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2951004 · Received February 8, 2013

    Report

    Report Number
    3007566237-2013-00434
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    January 14, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4), ANALYSIS OF THE PUMP FOUND NO ANOMALY. A MOTOR STALL RECOVERY WAS DISCOVERED IN THE LOGS, WHICH INDICATED THAT IN THE PUMP'S LIFE THERE WAS AT ONE TIME A MOTOR STALL AND THEN RECOVERY. NOTHING SIGNIFICANT WAS FOUND THAT MAY HAVE CAUSED THE MOTOR STALL.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP WAS EXPLANTED. THE REASON FOR EXPLANT WAS "NON EFFECTIVE BACLOFEN PUMP." A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF EVENT WAS "POOR RESPONSE TO TREATMENT." THE EVENT WAS ATTRIBUTED TO DRUG EFFECTS AND THE ISSUE WAS 'SEVERE DYSTONIA." IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED DUE TO THE EVENT. THE PATIENT WAS "NOW TREATED WITH DEEP BRAIN STIMULATION." THE PATIENT OUTCOME WAS NOTED AS NO INJURY. THE PUMP WAS BEING USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53833 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention