BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2180957 · Received July 22, 2011

    Report

    Report Number
    3004209178-2011-05682
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD NOT MADE AN APPOINTMENT FOR A REFILL; AND AS A RESULT, THE PUMP RAN OUT OF DRUG. THE PT EXPERIENCED MILD WITHDRAWAL SYMPTOMS AND VISITED THE EMERGENCY DEPARTMENT (ED). THE PUMP WAS LATER REFILLED, AND A BOLUS WAS GIVEN. THE LOW RESERVOIR AND CRITICAL PUMP ALARMS WERE CHANGED/UPDATED TO OCCUR EVERY 10 MINS. FULL RESOLUTION OF THE ISSUE WAS NOTED. THE PT WAS NOT INJURED, AND HAD RECOVERED WITHOUT SEQUELAE. THE DRUG INFUSED VIA THE PUMP WAS LIORESAL, DOSAGE UNK. ADDITIONAL INFO WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT 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 43 YR Other CATHETER: MODEL 8709, LOT# J11623R41| EXPLANTED:| IMPLANTED: