BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2925426 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00832
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    December 31, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709 LOT# J11297R47, IMPLANTED: 2002 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP ALARM WAS HEARD BY THE PATIENT "SINCE (B)(6)", AND A CRITICAL ALARM WAS CONFIRMED BY TELEMETRY DUE TO THE PUMP RESERVOIR VOLUME REACHING ZERO MILLILITERS (ML). THE LAST REFILL DATE WAS ON (B)(6) 2012 WHEN 20 CUBIC CENTIMETERS (CC) OF DRUG WAS PUT IN THE RESERVOIR. THE LOW RESERVOIR ALARM DATE WAS (B)(6) 2012 AND THE LOW RESERVOIR ALARM VOLUME WAS PROGRAMMED TO 2 CC. PROGRAMMING INDICATED THAT 20.7 CC WOULD HAVE BEEN DELIVERED. THE PATIENT HAD ACHINESS IN THE LEGS THAT BEGAN 2 TO 3 DAYS PRIOR TO THE DATE OF THE REPORT. THE PUMP WAS BEING USED TO DELIVER MORPHINE AND BACLOFEN. 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
    29004 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1