BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3242876 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12171
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    June 27, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PATIENT PROGRAMMER MODEL 8835, SERIAL# (B)(4), IMPLANTED: NA, EXPLANTED: NA; CATHETER MODEL 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SPINAL CORD INJURY (SYMPTOMS AND DATE OF ONSET WERE NOT REPORTED) AND WAS GOING TO HAVE MAGNETIC RESONANCE IMAGING (MRI) DONE OF HER ¿T-SPINE,¿ ¿MID-BACK,¿ THE DAY OF THE INITIAL REPORT.THE MRI WAS BEING DONE TO ¿RULE OUT CORD TETHERING,¿ IT WAS ¿ASSUMED¿ TO BE RELATED TO THE SYSTEM AS THE SYSTEM WAS IMPLANTED SIX WEEKS BEFORE THE INITIAL REPORT. WHEN ASKED ¿TETHERING, MEANING THE CATHETER, THAT THEY¿RE--¿ THE CALLER RESPONDED ¿UM-HUM,¿ IT WAS UNCLEAR WHAT WAS MEANT.ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342884 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1