BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3120673 · Received May 20, 2013

    Report

    Report Number
    6000030-2013-00117
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8578, LOT# N084002, IMPLANTED: 2007-(B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID 8578, LOT# N084002, IMPLANTED: 2007-(B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: AS OF (B)(6) 2013, THE PATIENT STILL HAD PRETTY GOOD SPASTICITY RELIEF AT A LOW DOSE. THE SIDE PORT STUDY WAS DONE AS PREP FOR A ROUTINE PUMP REPLACEMENT FOR BATTERY LIFE. UPON SURGICAL DISSECTION OF THE POCKET ON (B)(6) 2013, THE CATHETER WAS EASILY ASPIRATED WITHOUT DIFFICULTY. A SUCCESSFUL MYELOGRAM WAS PERFORMED AND THE CATHETER WAS FOUND TO BE PATENT. THE PUMP WAS REPLACED AS PLANNED. THERE TURNED OUT TO BE NO ISSUE WITH CATHETER PATENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY WERE UNABLE TO ASPIRATE THE CATHETER AS PART OF A WORKUP FOR PUMP REPLACEMENT. THEY PLANNED TO REPLACE THE CATHETER DURING THE PUMP REPLACEMENT. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT; THE PATIENT WAS GETTING CONTINUED ADEQUATE SPASTICITY RELIEF. THE PATIENT STATUS WAS REPORTED AS ¿ALIVE - NO INJURY/NO ADVERSE EVENT¿. THE PUMP WAS DELIVERING COMPOUNDED BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221427 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention