BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2073570 · Received April 26, 2011

    Report

    Report Number
    3004209178-2011-03115
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    December 17, 2009
    Report Date
    April 11, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A LOSS OF THERAPEUTIC RELIEF. THE CATHETER WAS SPLICED ON (B)(6) 2010. THE PT WAS STARTED ON A FENTANYL 150MCG/HR PATCH ON (B)(6) 2009 WHICH WAS INCREASED TO 200MCG/HR ON (B)(6) 2010. A SURGICAL REVISION OF THE CATHETER WAS DONE ON (B)(6) 2010. THE PT RESOLVED WITHOUT SEQUELA ON (B)(6) 2010. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention CATHETER: MODEL 8703W, LOT# L38317| CATHETER: MODEL 8709, LOT# N152112032| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# N152112032| CATHETER: MODEL 8703W, LOT# L38317| EXPLANTED:| IMPLANTED: