BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3870112 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-11498
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 22, 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
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4):ANALYSIS OF THE CATHETER REVEALED NO SIGNIFICANT ANOMALY, CATHETER BODY DRIED DRUG, BLOOD OR FOREIGN MATERIAL OCCLUSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT STARTED HAVING SYMPTOMS "VERY RECENTLY/WEEKS." THE PATIENT HAS SPORADIC RESULTS WITH DIFFERING RESPONSES DEPENDENT UPON POSITIONING. IT WAS INDICATED THERE WAS A POSSIBLE CATHETER ISSUE. A CATHETER REPLACEMENT OR REVISION WAS PLANNED. THE PUMP WAS USED TO DELIVER LIORESAL. ADDITIONAL INFORMATION LATER REPORTED THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT/CATHETER REVISION. ALTHOUGH CAT HETER REVISION WAS STATED BY THE REPORTER IT WAS NOT STATED WHEN THE REVISION OCCURRED. ADDITIONAL INFORMATION WAS REQUESTED, A FOLLOW-UP REPORT WILL BE SENT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER RECEIVED REPORTED THE CATHETER ISSUE WAS FRACTURED PROXIMAL SEGMENT. THE LOCATION OF THE ISSUE WAS THE PROXIMAL/PUMP SEGMENT. A REVISION OF THE PROXIMAL SEGMENT WAS DONE. TO THE REPORTERS KNOWLEDGE THE PATIENT WAS DOING WELL BUT HAD NOT HEARD SPECIFICALLY ONE WAY OR THE OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347954 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00006 YR Required Intervention