BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2250670 · Received September 13, 2011

    Report

    Report Number
    3004209178-2011-07775
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    August 27, 2010
    Report Date
    September 7, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT EXPERIENCED BACLOFEN WITHDRAWAL. THE PT EXPERIENCED THE FOLLOWING SIGNS AND/OR SYMPTOMS: "BACLOFEN WITHDRAWAL, LIGHT-HEADED, INCREASED TREMOR, SHAKING". A CATHETER DISLODGEMENT FROM THE INTRATHECAL SPACE WAS INDICATED. THE CATHETER WAS REPLACED ON (B)(6) 2010. THE DETERMINATION OF SEVERITY FOR THE PT WAS "SEVERE." THE PT'S MEDICATION (BACLOFEN 2,000 MCG/ML CONCENTRATION) WAS INCREASED BY 29% FROM 209.8 MCG/DAY TO 270.2 MCG/DAY. THE PT'S OUTCOME WAS NOTED AS HAVING HAD RESOLVED WITHOUT SEQUELA. ADDITIONAL INFORMATION 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 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# N249254004