BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1983996 · Received February 7, 2011

    Report

    Report Number
    3004209178-2011-00941
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN FELT THE PT WAS EXPERIENCING BACLOFEN WITHDRAWAL; NO SPECIFIC SYMPTOMS OR THERAPY INFO WAS PROVIDED. THE HEALTHCARE PROVIDER WANTED THE PUMP READ TO CONFIRM ITS FUNCTION. THE DEVICE SYS WAS USED TO DELIVER BACLOFEN. A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other IMPLANTED:| CATHETER: MODEL 8731SC, LOT# N134759001| EXPLANTED: