BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2912645 · Received January 14, 2013

    Report

    Report Number
    3004209178-2013-00503
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8780, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A DOSE INCREASE EARLIER IN THE DAY ON (B)(6) 2012 AND WAS EXPERIENCING "ALTERED MENTAL STATUS" AND WAS LETHARGIC. THE HEALTHCARE PROVIDER (HCP) PLANNED TO INTERROGATE THE PUMP. THE HCP INDICATED THEY MAY POSSIBLY MOVE THE PATIENT TO ANOTHER FACILITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. DRUG DELIVERED VIA THE DEVICE WAS BACLOFEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPROPER CATHETER ASPIRATION TECHNIQUE HAD OCCURRED. THE PATIENT RECEIVED INCREASE DOSE AND HAD SYMPTOMS OF SEDATION AND HOSPITALIZATION. SIDE EFFECTS WERE TRANSIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20013 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| O