BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3003978 · Received March 14, 2013

    Report

    Report Number
    3004209178-2013-03707
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8835 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT HAD A CEREBRAL SPINAL FLUID (CSF) LEAK NEAR THE DURA WHERE THE CATHETER ENTERED THE INTRATHECAL SPACE. THE PATIENT HAD RECEIVED PAIN RELIEF SINCE IMPLANT BUT HAD HEADACHES. THE CSF LEAK WAS REPAIRED ON (B)(6) 2013 AND THE CATHETER WAS FOUND INTACT . NO PATIENT INJURY WAS REPORTED. THIS DEVICE SYSTEM WAS USED TO DELIVER PRIALT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107013 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Required Intervention