BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3653534 · Received February 28, 2014

    Report

    Report Number
    3004209178-2014-03761
    Event Type
    Injury
    Date Received
    February 28, 2014
    Report Date
    February 6, 2014
    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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALY FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED MULTIPLE MOTOR STALLS OCCURRED FOLLOWING A MAGNETIC RESONANCE IMAGING (MRI) ON (B)(6) 2014 AND THE PATIENT EXPERIENCED INCREASED DEPRESSION AT THE TIME OF THE MOTOR STALLS. ON (B)(6) 2013 A MOTOR STALL OCCURRED AT 12:55 AND RECOVERED AT 14:30 AND A SECOND MOTOR STALL OCCURRED ON (B)(6) 2013 AND STOPPED PUMP PERIOD MAY EXCEED TUBE SET OCCURRED ON (B)(6) 2013. IT WAS ALSO NOTED A MOTOR STALL RECOVERY OCCURRED ON (B)(6) 2014. THE PUMP WAS BEING USED TO DELIVER BACLOFEN. IT WAS FURTHER REPORTED THE PATIENT EXPERIENCED A LOSS OF PAIN RELIEF AND INCREASED PAIN AT THE TIME OF THE MOTOR STALLS. THE EVENT WAS RELATED TO THE DEVICE OR THERAPY AND NOT RELATED TO THE IMPLANT PROCEDURE. IT WAS REPORTED INTERVENTIONS INCLUDED REPROGRAMMING AND ON (B)(6) 2014 THE PUMP WAS REPROGRAMMED WITH AN INCREASED RATE OF 9% AND THE DAILY DOSE WAS INCREASED AGAIN ON (B)(6) 2014 WITH AN INCREASED CONTINUOUS RATE OF 34%. ON (B)(6) 2014 THE INCREASED CONTINUOUS RATE WAS 25% FOR THE PUMP DAILY DOSE. THE PUMP WAS REPLACED ON (B)(6) 2014 26 AND THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123989 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention