BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3122449 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-07981
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 1, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# L36861, IMPLANTED: (B)(6) 1997. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH WITHDRAWAL SYMPTOMS. AS OF (B)(6) 2013, THE PATIENT WAS IN THE ICU; SHE WAS CONFUSED AND DELIRIOUS. THE PUMP WAS LAST FILLED IN (B)(6). THEY PLANNED TO CHECK THE PUMP TO SEE IF IT STILL HAD DRUG OR IF IT WAS EMPTY. THE PUMP WAS DELIVERING MORPHINE. IT WAS LATER REPORTED THAT A PUMP REFILL WAS PLANNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223621 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization