BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4840831 · Received June 12, 2015

    Report

    Report Number
    3004209178-2015-11529
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Report Date
    May 18, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOTOR STALL WAS RECORDED IN A SESSION DATA REPORT. THE REPORT INDICATED THAT (B)(6) 2013 THE STALL OCCURRED AT 13:30 AND RECOVERED 13:59. THE PUMP WAS USED TO INFUSE BACLOFEN AT THE TIME OF THE EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PUMP HAD STALLED DURING A MAGNETIC RESONANCE IMAGING (MRI) SCAN ON (B)(6) 2013 TO CHECK THE STATUS OF CHIARI ONE MALFORMATION. THE MRI WAS PERFORMED WITHOUT CONTRAST NOTING LIGAMENTUM FLAVUM REDUNDANCY AT C3-C4 RESULTING IN MILD PROGRESSION OF SPINAL STENOSI AT THIS LEVEL. THE OUTCOME WAS REPORTED AS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013. THE PATIENT EXPERIENCED NO SIGNS OR SYMPTOMS. NO ACTIONS OR INTERVENTIONS OCCURRED NOR NO DIAGNOSTIC METHODS. THE ETIOLOGY WAS REPORTED AS RELATED TO THE DEVICE OR THERAPY AND NOT TO THE IMPLANT PROCEDURE. THIS DEVICE SYSTEM DELIVERED LIORESAL. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384709 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR