BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4151075 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18474
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    September 12, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER FOUND NO SIGNIFICANT ANOMALY. THE CATHETER REVEALED ACCEPTABLE TESTING AND HAD BEEN INCOMPLETE AS IT WAS RETURNED IN SEGMENTS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS FOR THE CATHETER WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

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

    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 THAT THE PUMP STOPPED HELPING FOLLOWING A FALL. IT WAS UNKNOWN IF THE EVENT WAS DUE TO THE FALL OR A TITRATION EXPERIENCE. THE PATIENT WAS GIVEN 2 WEEKS TO HEAL, BUT STILL HAD NO PAIN RELIEF. FLUID (3ML) WAS EASILY ASPIRATED FROM THE CATHETER ACCESS PORT (CAP) PRIOR TO A DYE STUDY THAT WAS PERFORMED THE DAY OF THE REPORT. THE DYE WAS FOUND IN THE PUMP POCKET; 25ML OF DYE AND SEROUS FLUID WAS ASPIRATED FROM THE POCKET. IT WAS SUSPECTED THAT THE CATHETER DISCONNECTED FROM THE PUMP. A ROLLER STUDY CONFIRMED THE PUMP WAS OK. THE PATIENT WAS TO MEET THE SURGEON ON (B)(6) 2014 TO SCHEDULE A REVISION. IT WAS NOTED THAT THE PATIENT¿S ORAL PERCOCET WAS INCREASED FROM 4 TO 8 MG PER DAY. THE REVISION TOOK PLACE ON (B)(6) 2014 AND WHEN THE POCKET WAS OPENED, NOTHING WAS WRONG WITH THE CATHETER. IT WAS STILL CONNECTED. HOWEVER, A TWIST WAS SEEN IN THE CATHETER, JUST DISTAL TO THE COLLET. THE REPORTER DID NOT BELIEVE THE CATHETER TO BE OCCLUDED. THE CATHETER WAS CUT JUST DISTAL TO THE TWIST AND GREAT CEREBROSPINAL FLUID (CSF) FLOW WAS SEEN. A CLAMP WAS THEN PLACED ON THE DISTAL SEGMENT OF THE CATHETER AND THE PROXIMAL SEGMENT WAS LEFT ATTACHED TO THE PUMP. FLUID WAS THEN ATTEMPTED TO BE INJECTED INTO THE CATHETER TO SEE IF THERE WAS A LEAK. NOTHING WAS REPORTEDLY ABLE TO BE INJECTED INTO THE CATHETER. THE PROXIMAL SEGMENT WAS THEN REPLACED. THE CAP WAS THEN ASPIRATED AND DYE WAS INJECTED TO CONFIRM A GOOD CONNECTION. THE DYE WENT THROUGH ¿BEAUTIFULLY.¿ THE DOSAGE WAS DECREASED TO THE STARTING DOSE; DUE TO THE PATIENT BEING SYMPTOMATIC PRIOR TO THE REVISION. THE HEALTHCARE PROVIDER (HCP) THOUGH THE PATIENT WAS NOT GETTING ANYTHING WITH THE OLD CATHETER. THE PUMP WAS USED TO DELIVER DILAUDID. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY NOW. THE PATIENT STARTED TO BE WEANED OFF ORAL MEDICATION ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633361 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Required Intervention