BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3201743 · Received July 2, 2013

    Report

    Report Number
    6000030-2013-00173
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 12, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8711, LOT# J11190R12, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PREVIOUSLY EXPERIENCED WITHDRAWAL/WITHDRAWAL SYMPTOMS DUE TO A CATHETER BREAK THAT REPORTEDLY OCCURRED ¿THE LAST TWO TIMES THE PUMP HAS BEEN IMPLANTED¿. DUE TO THE EVENT, THE PATIENT WASN¿T RECEIVING MEDICATION FROM THE PUMP. THE FIRST CATHETER BREAK REPORTEDLY OCCURRED ¿SOMETIME¿ IN 2002. THE SECOND TIME THE CATHETER BROKE, IT WAS ¿ANTICIPATED¿ WHEN THE PATIENT WENT IN FOR A PUMP REPLACEMENT IN AUGUST OF 2008. IT WAS NOTED, ¿WHEN THEY WENT IN LAST TIME THEY ANTICIPATED THE CATHETER BROKE AGAIN BECAUSE I¿M PROBABLY A LOT MORE ACTIVE THAN MOST PEOPLE WITH THESE PUMPS¿. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301725 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention