BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3143187 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08560
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 8, 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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALY FOUND. ANALYSIS OF THE CATHETER BODY REVEALED A HOLE CAUSED BY DEEP ABRASION; USER RELATED HOLE. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A ¿SUDDEN INCREASE OF SPASMS" NOT FEELING WELL, AGITATED AND NOT SLEEPING. THE SYMPTOMS STARTED (B)(6) 2013. A DYE STUDY DONE WAS DONE. THE RESULTS WERE NORMAL; THE CATHETER WAS IN PLACE. THE PUMP WAS INTERROGATED. BOLUSES WERE GIVEN WITH IMPROVEMENT. THE PATIENT WAS ASSESSED FOR AN INFECTION. A TEST WAS DONE FOR INFECTION; NONE WAS FOUND. THE PHYSICIAN BELIEVED IT WAS BEST TO REPLACE THE SYSTEM. THE DEVICE WAS EXPLANTED. THE PATIENT WAS HOSPITALIZED. THERE WAS NO KNOWN EVENT OR CAUSE OF THE SYMPTOMS. THE PATIENT STATUS WAS ALIVE, NO INJURY, NO ADVERSE EVENT. THE PUMP WAS DELIVERING COMPOUNDED BACLOFEN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245307 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00033 YR Hospitalization| R