BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1192074 · Received October 7, 2008

    Report

    Report Number
    3004209178-2008-06412
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 10, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS ADMITTED TO HOSPITAL DUE TO SHOCKING NEAR PUMP POCKET, ACUTE PAIN, BACK PAIN, HEADACHE AND NAUSEA. THE ALARM DATE WAS SET FOR THE SAME DAY THAT THE PT WAS ADMITTED TO THE HOSPITAL. THE PT HAD MOVED AND HAD BEEN UNABLE TO FIND AN HCP TO REFILL THE PUMP. THE PT REPORTED THE DRUG IN THE PUMP WAS BACLOFEN, BUT WAS WORKING WITH THE CURRENT HCP TO SWITCH TO BUPIVACAINE AND MORPHINE AS THE PT ONLY WANTED THE PUMP FOR PAIN THERAPY. THE PT AND HCP HAVE BEEN WAITING FOR THE PT'S RECORDS IN ORDER TO SWITCH TO THE NEW DRUGS. NO FURTHER OUTCOME WAS REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL 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 42 YR Hospitalization| R EXPLANTED| PROGRAMMER MODEL 8840 LOT#UNK| CATHETER MODEL 8709SC LOT #N128053007| IMPLANTED