BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2230565 · Received August 12, 2011

    Report

    Report Number
    3004209178-2011-06299
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 22, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CRITICAL ALARM WAS HEARD AND CONFIRMED BY TELEMETRY. THE PUMP WAS IN SAFE STATE; RESET OCCURRED WITH "LOW BATTERY AND MOTOR STALL". THEY WERE UNABLE TO RESTART THE PUMP. THE PT EXPERIENCED WITHDRAWAL AND WAS ADMITTED TO THE HOSP. THE PUMP WAS REMOVED PER PT REQUEST. THE PUMP CONTAINED MORPHINE 40 MG/ML, BUPIVICAINE 10 MG/ML AND BACLOFEN 2000 MCG/ML. THE PT WAS HOME AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R CATHETER: MODEL 8596SC, LOT# N112990014| CATHETER: MODEL 8709, LOT# J12388R33| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED: