BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2707816 · Received August 21, 2012

    Report

    Report Number
    3004209178-2012-07147
    Event Type
    Injury
    Date Received
    August 21, 2012
    Report Date
    July 27, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL# 8709SC, LOT# N175091008, IMPLANTED: 2009 (B)(6), EXPLANTED: UNK. ACCESSORY MODEL# 8590-1, LOT# N180847, IMPLANTED: 2009 (B)(6), EXPLANTED: UNK. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AN ALARM WAS HEARD; TELEMETRY DID NOT CONFIRM THE ALARM. THE PATIENT HAD A REFILL (B)(6) 2012 WITH NO ISSUES, EVERYTHING WENT FINE. THE PATIENT THOUGHT SHE HAD HEARD THE PUMP ALARM VERY FAINT A COUPLE DAYS PRIOR. CALLER STATED THE LAST TIME THE PUMP ALARMED THE PATIENT DID NOT HEAR IT CLEARLY, SHE THOUGHT IT WAS THE GARAGE DOOR AND ENDED UP IN THE HOSPITAL. CALLER STATED SHE HAD 3.5ML LEFT AND THE ERI WAS 38 MONTHS. FURTHER TROUBLESHOOTING WAS BEING CONSIDERED. THE PUMP WAS DELIVERING DILAUDID AND MARCAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization