BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1051621 · Received May 21, 2008

    Report

    Report Number
    3004209178-2008-02682
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 21, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THE PT WAS HOSPITALIZED DUE TO AN INFECTION. A SEROMA OF ABNORMAL SUBCUTANEOUS FLUID HAD ACCUMULATED AT THE PUMP POCKET SITE. THE HCP HAD ATTEMPTED TO REMOVED DRUG FROM THE RESERVOIR AND PULLED BACK 5 CC OF YELLOW CLOUDY FLUID. THE FLUID WAS NEGATIVE FOR DRUG AND CULTURES WERE PENDING. THE PT'S PUMP WAS DUE TO ALARM AND NEEDED TO BE REFILLED, BUT THERE WAS CONCERN DUE TO THE POSSIBLE INFECTION. THE PT HAD EXPERIENCED NO CHANGE IN SPASTICITY. THE PT WAS MANAGED FOR PREVENTION OF BACLOFEN WITHDRAWAL. FOLLOW UP WITH THE HCP REVEALED THE PT WAS ADMITTED TO THE HOSPITAL IN 2008 FOR AN INFECTIOUS DISEASE CONSULT. A CT OF THE POCKET SITE WAS DONE TO RULE OUT AN ABSCESS. THE HCP FOUND NO ABSCESSES, NO CELLULITIS, AND POCKET SITE CULTURES WERE NEGATIVE. THE PT WAS TREATED WITH IV ANTIBIOTICS AND WAS DISCHARGED SIX DAYS LATER. THE PT'S PUMP WAS REFILLED UPON DISCHARGE WITH NO CHANGES TO DOSAGE. THE DRUG USED IN THE PUMP WAS LIORESAL 500 MCG/ML.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R IMPLANTED| CATHETER MODEL 8709 LOT #N098122012| PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED