BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3031385 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04498
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 5, 2013
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT PROGRAMMER MODEL 8835, SERIAL# (B)(4), IMPLANTED: NA, EXPLANTED: NA, CATHETER MODEL 8731, SERIAL# (B)(4), IMPLANTED: 2004-(B)(6), EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    A NON-CRITICAL ALARM WAS HEARD ON THE MORNING OF THE INITIAL REPORT, CONFIRMED BY TELEMETRY WITH PATIENT PROGRAMMER THERAPY MANAGER (PTM.) PTM REVEALED CODE 8254 FOR LOW RESERVOIR VOLUME REACHED. NEXT REFILL WAS SCHEDULED FOR (B)(6) 2013. TWO WEEKS AFTER THE INITIAL REPORT, IT WAS ADDED THAT THE PATIENT STILL HAD CONCERNS REGARDING HER DEVICE OR THERAPY AND SHE WAS WORKING WITH HER DOCTOR WITH AN APPOINTMENT DATE (B)(6) 2013/DYE STUDY/PUMP REVISION. THE DEVICE SYSTEM WAS USED TO INFUSE FENTANYL AND BUPIVACAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134507 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention