BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4200273 · Received October 24, 2014

    Report

    Report Number
    3004209178-2014-20352
    Event Type
    Injury
    Date Received
    October 24, 2014
    Report Date
    October 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A FLIPPED PUMP WAS CONFIRMED AND THERE WERE PLANS TO FLIP THE PUMP ON (B)(6) 2014. IT WAS NOTED DIAGNOSTIC TESTING OR TROUBLESHOOTING PERFORMED INCLUDED X-RAYS; HOWEVER THE CAUSE OF THE ISSUE WAS UNDETERMINED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT AND THE PATIENT¿S STATUS AT THE TIME OF THIS REPORT WAS ¿ALIVE-NO INJURY.¿ THE CAUSE OF THE PUMP FLIP, THE DATE OF X-RAY PERFORMED, FURTHER TROUBLESHOOTING OR ACTIONS TAKEN TO RESOLVE THE EVENT PRIOR TO THE REVISION, IF THE ISSUE WAS CORRECTED, AND THE PATIENT OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. THE PUMP WAS BEING USED TO DELIVER COMPOUNDED BACLOFEN.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT, POST-OPERATIVELY, THE PATIENT EXPERIENCED OVERDOSE SYMPTOMS, SPECIFIED AS DROWSINESS AND AN INABILITY TO MOVE HIS LEGS DUE TO WEAKNESS. A CATHETER KINK AT THE PUMP CONNECTOR OCCURRED. REPROGRAMMING WAS REQUIRED. THE PATIENT STATUS AT THE TIME OF THIS EVENT WAS INDICATED TO BE ¿ALIVE-NO INJURY.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE SYSTEM DELIVERED GABLOFEN. THE CAUSE OF THE EVENT WAS THE PATIENT'S WEIGHT. SHE WAS OBESE AND HAD LIMITED MOBILITY OF MAINLY THE RIGHT SIDE. BECAUSE OF THAT THE PATIENT'S WEIGHT AND BODY POSITIONING WORE AT THE SUTURING. THE PUMP POCKET WAS REVISED AND WAS RE-SUTURED IN A WAY THE NEUROSURGEON FELT WAS OPTIMAL. THE PATIENT WAS GETTING EFFECTIVE THERAPY AND HAD NOT HAD ANY FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679824 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention