BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4987931 · Received August 10, 2015

    Report

    Report Number
    3007566237-2015-02222
    Event Type
    Injury
    Date Received
    August 10, 2015
    Date of Event
    July 15, 2015
    Report Date
    July 15, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8575, LOT# N173834, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709, LOT# L57103, IMPLANTED: (B)(6) 1998, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM AN HEALTHCARE PROVIDER (HCP), VIA A COMPANY REPRESENTATIVE, REGARDING A PATIENT RECEIVING GABLOFEN (2000 MCG/ML) AT 374.3 MCG/DAY VIA AN IMPLANTABLE PUMP. INDICATIONS FOR USE INCLUDED CEREBRAL PALSY, FAMILIAL SPASTIC PARAPARESIS, AND INTRACTABLE SPASTICITY. CONCOMITANT MEDICAL PRODUCTS AND MEDICAL HISTORY WERE UNKNOWN. ON (B)(6 2015, DURING A PROCEDURE TO CHANGE THE PUMP DUE TO NORMAL BATTERY DEPLETION, THE CATHETER DID NOT ASPIRATE. DIAGNOSTIC TESTING INCLUDED ONLY THE ATTEMPTED CATHETER ASPIRATION; THE SPINAL SEGMENT WAS "DISCONNECTED TO THE PUMP SEGMENT." NO PATIENT SYMPTOMS WERE REPORTED. A PARTIAL EXPLANT WAS PERFORMED. THE HEALTHCARE PROVIDER (HCP) REMOVED THE OLD CATHETER AND INSERTED A NEW COMPANY CATHETER; THE SPINAL SEGMENT WAS LEFT IN PLACE. THE REMOVED CATHETER SEGMENT WAS DISCARDED. FOLLOWING PLACEMENT OF THE NEW CATHETER, THE EVENT WAS RESOLVED; THE PATIENT'S STATUS WAS REPORTED AS "ALIVE - NO INJURY." THE HCP HAD NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER INDICATING THAT THE CATHETER HAD AN ISSUE WITH GETTING CLOGGED. REFER TO MANUFACTURER'S REPORT #3004209178-2015-17276 FOR INFORMATION REGARDING THE PATIENT'S DIFFICULTIES FOLLOWING THE SURGERY ON (B)(6) 2015-07-15.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523208 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention