BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 5172686 · Received October 24, 2015

    Report

    Report Number
    6000030-2015-00163
    Event Type
    Injury
    Date Received
    October 24, 2015
    Report Date
    October 1, 2015
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO HAD BEEN RECEIVING INTRATHECAL BACLOFEN VIA AN IMPLANTED INFUSION PUMP. THE PUMP'S INDICATION FOR USE (IFU) WAS LISTED AS SPINAL CORD INJURY/SPINAL CORD DISEASE AND INTRACTABLE SPASTICITY. FROM THE IMPLANT DATE IN 2002 UNTIL 2004 THE PATIENT'S CATHETER SHEARED MULTIPLE TIMES. A POSSIBLE CAUSE WAS THAT THE PATIENT WAS VERY ACTIVE AND VERY THIN. THE PATIENT WAS VERY SENSITIVE TO SPINAL PRESSURE CHANGES AND TWO TIMES HE HAD SEVERE SPINAL HEADACHES THAT LASTED FOR A WEEK. IN 2004, THE PATIENT CHOSE TO STOP USING THE PUMP AND CATHETER BECAUSE OF THE SURGERIES TO REPLACE/REPAIR THE CATHETER. FOLLOW-UP IS BEING CONDUCTED FOR DRUG INFORMATION, OTHER MEDICATIONS THAT THE PATIENT WAS TAKING AT THE TIME OF THE EVENT, MEDICAL HISTORY, SPECIFIC DATES AND CAUSES OF THE CATHETER ISSUES/HEADACHES, TROUBLESHOOTING, DIAGNOSTICS AND ACTIONS/INTERVENTIONS TAKEN TO RESOLVE THE ISSUE. REFER TO MANUFACTURER REPORT # 6000030-2015-00161 FOR THE EVENT RELATED TO THE CATHETER IMPLANTED IN (B)(6)-2002. REFER TO MANUFACTURER REPORT # 6000030-2015-00162 FOR THE EVENT RELATED TO THE CATHETER IMPLANTED IN (B)(6)-2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704840 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627-18

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Required Intervention