BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1833187 · Received September 9, 2010

    Report

    Report Number
    3004209178-2010-06909
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    June 1, 2010
    Report Date
    August 9, 2010
    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
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS NOT RECEIVING ANY THERAPEUTIC EFFECT IN REGARDS TO THEIR SPASTICITY. THE ANESTHESIOLOGIST WAS HAVING A HARD TIME EXTRACTING THE DRUG FROM THE CATHETER THRU THE CATHETER ACCESS PORT. THE PHYSICIAN CHANGED THE ANGLE OF THE NEEDLE, AND WAS ABLE TO SUCCESSFULLY EXTRACT THE DRUG. THE PT WAS NOT HARMED DURING THE PROCEDURE. A DYE STUDY WAS PERFORMED IN REGARDS TO THE CATHETER. THE PUMP CONTAINED BACLOFEN, "1000 CONCENTRATION" WITH A DOSE OF 306 MCG/DAY. THE PHYSICIAN DID NOT BELIEVE THE INTRATHECAL LIORESAL CAUSED THE EVENT. REGARDING WHETHER ANY COMPONENT WAS EXPLANTED OR REPLACED AND IF SO, WOULD IT BE RETURNED TO THE MFR, IT WAS NOTED "NO". DEVICE REGISTRATION INFO, INCLUDED WITH THE REPORTED INFO, INDICATED A CATHETER REVISION OCCURRED ON (B)(6)2010. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention CATHETER: MODEL CATHETER, LOT# UNK| EXPLANTED:| IMPLANTED: