BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2162108 · Received July 12, 2011

    Report

    Report Number
    3004209178-2011-05347
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    January 1, 2009
    Report Date
    June 20, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT WAS HOSPITALIZED FOLLOWING A PROCEDURE (NOT SPECIFIED). THE PT HAD AN INFECTION AFTER THE PROCEDURE; THE REPORTER WAS UNSURE WHERE THE INFECTION BEGAN. BECAUSE OF THE INFECTION, THE PUMP WAS REMOVED. THE PT EXPERIENCED BACLOFEN WITHDRAWAL. THE PT EXPERIENCED A CARDIAC ARREST DUE TO THE BACLOFEN WITHDRAWAL. THE PT EXPIRED; THE CAUSE OF DEATH WAS CARDIAC ARREST. IT WAS BELIEVED THE CAUSE OF DEATH WAS PUMP-RELATED. A F/U REPORT WILL BE SENT IF ADD'L 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 44 YR Death| H| L| R IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8711, LOT# J11418R46| IMPLANTED:| CATHETER: MODEL 8711, LOT# J11442R21| EXPLANTED: