BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3132856 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08293
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 1, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8598, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER: PRODUCT ID 8596, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INCREASED TONE. AN X-RAY WAS PERFORMED AND SHOWED THAT THE CATHETER HAD PULLED BACK OUT OF THE INTRATHECAL SPACE. THE TIP WAS PROJECTING IN THE POSTERIOR SOFT TISSUE AT THE 3RD LUMBAR VERTEBRA. THE METALLIC MARKER FROM THE TIP OF THE CATHETER REMAINED IN THE INTRATHECAL SPACE AND WAS PROJECTING AT THE 5TH LUMBAR VERTEBRA. A CATHETER REPLACEMENT WAS PERFORMED. THE SPINAL SEGMENT OF THE CATHETER REMAINED IN THE INTRATHECAL SPACE AS IT HAD BROKEN OFF AT THE SPINAL CONNECTION SITE. THE PROXIMAL CATHETER WAS EXPLANTED, BUT THAT SEGMENT WAS NOT ¿IMPLICATED¿ AS BEING RELATED TO THE EVENT. AT THE TIME OF REPORT, THERE WAS NO PATIENT INJURY OR ADVERSE EVENT, THOUGH IT WAS NOTED THAT THE PATIENT HAD BEEN HOSPITALIZED. THE DEVICE SYSTEM WAS DELIVERING GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237493 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R