BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2032364 · Received March 28, 2011

    Report

    Report Number
    3004209178-2011-02329
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    May 1, 2010
    Report Date
    March 16, 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
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), (LOSS OF APPETITE), (B)(4).

    Description of Event or Problem · 1

    A DYE STUDY WAS PERFORMED IN (B)(6) 2009; THE PATIENT WAS TOLD THE PUMP WAS WORKING AS INTENDED. FROM (B)(6) TO (B)(6) 2010 THE PUMP WAS "INTERMITTENTLY" INFUSING MORPHINE. THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS; NAUSEA, DIARRHEA, LOSS OF APPETITE, AND LOSS OF SLEEP. THE PHYSICIAN RULED OUT "ANXIETY ATTACKS." THE PUMP BATTERY "HAS BEEN DRAINING," THE PUMP PRINT-OUT INDICATED THERE WERE 28 MONTHS OF BATTERY LIFE REMAINING. THE PLAN WAS TO REPLACE THE PUMP ON (B)(6) 2011. AT THE TIME OF THIS REPORT, THE PUMP CONTAINED SALINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other EXPLANTED:| CATHETER: MODEL 8709, LOT# N081425029| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# N070768019| IMPLANTED: