BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5060690 · Received September 8, 2015

    Report

    Report Number
    3007566237-2015-02520
    Event Type
    Injury
    Date Received
    September 8, 2015
    Date of Event
    January 1, 2011
    Report Date
    August 13, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8590-1, LOT# N232313, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL REGARDING A PATIENT RECEIVING INTRATHECAL BACLOFEN VIA AN IMPLANTED INFUSION PUMP. THE PUMP'S INDICATION FOR USE (IFU) WAS LISTED AS CEREBRAL PALSY AND INTRACTABLE SPASTICITY. THE PATIENT HAD NEVER REACHED A DOSE THAT MANAGED HER TONE; THIS HAD BEEN GOING ON SINCE THE PUMP WAS FIRST IMPLANTED. A CATHETER REVISION HAD BEEN PERFORMED IN 2011; DETAILS REGARDING THE REASON FOR THE CATHETER REVISION WERE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FOR DRUG INFORMATION, PERTINENT MEDICAL HISTORY, RELATED SYMPTOMS, DATE OF THE ISSUE, CAUSE OF THE ISSUE, AND DIAGNOSTICS PERFORMED AND RESULTS. (B)(4). ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP). PATIENT HISTORY INCLUDED NO KNOWN ALLERGIES, SPASTIC QUADRIPARESIS, BORN WITH SEMILOBAR HOLOPROSENCEPHALY, CEREBRAL PALSY, DIABETES INSIPIDUS, GASTROESOPHAGEAL REFLUX DISEASE, DYSPHAGIA, MICROCEPHALY, NEUROMUSCULAR SCOLIOSIS, SUBLUX BILATERAL CONGENITAL HIPS, AND RIGHT HIP DISLOCATION. PRIOR TO EARLY 2013 OR LATE 2012, THE PUMP DELIVERED LIORESAL AND WAS THEN CHANGED TO GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593313 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00009 YR Required Intervention