BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1063244 · Received June 19, 2008

    Report

    Report Number
    3004209178-2008-03371
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 21, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT - CATHETER.

    Description of Event or Problem · 1

    THE PT HAD REDNESS AND SWELLING AROUND THE PUMP SITE. THE PUMP WAS USED TO DELIVER HIGH CONCENTRATIONS OF MORPHINE AND BACLOFEN. THE HCP DECIDE TO REPLACE BOTH THE PUMP AND CATHETER. DRUG WAS ASPIRATED FROM THE OLD PUMP TO FILL THE NEW PUMP. THE NEW PUMP WAS PRIMED WITH A 0.5MG THERAPEUTIC BOLUS AND PROGRAMMED TO DELIVER 15.5 MG/DAY. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention CATHETER MODEL 8709 LOT# L55913| IMPLANTED:| EXPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK