BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1031201 · Received April 18, 2008

    Report

    Report Number
    3004209178-2008-02090
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    December 1, 2007
    Report Date
    March 20, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.,
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT CONTINUES TO BE IN THE HOSP AFTER THE PUMP AND PROXIMAL CATHETER REVISION. THE PT HAS ALSO CONTINUED TO HAVE DELIRIUM/PSYCHOSIS; SHE GOES IN AND OUT OF CONSCIOUSNESS. AN INDIUM DYE STUDY WAS DONE WITH THE NEW PUMP/CATHETER; THERE WAS NO EVIDENCE OF LEAK. THERE WERE NO PUMP ALARMS. THE PT'S STATUS WAS REPORTED AS "SERIOUS". THE PUMP/CATHETER SYSTEM IS USED TO DELIVER BACLOFEN. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE. SEE MFR'S REPORT NUMBERS: 6000030200800390 AND 6000030200801156.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO., 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R EXPLANTED:| IMPLANTED:| LOT # UNK| EXPLANTED:| PROGRAMMER MODEL 8840| DISTAL CATHETER MODEL 8598| PROXIMAL CATHETER MODEL 8596| IMPLANTED: