BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1150251 · Received September 3, 2008

    Report

    Report Number
    2182207-2008-05415
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    June 1, 2008
    Report Date
    August 5, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT RECEIVED PRIALT VIA PUMP SYSTEM. THE INITIAL DOSE WAS 1.2 MCG/DAY WITH INCREASING DOSES TO 8 MCG/DAY. THE PT EXPERIENCED TACHYCARDIA (112 BPM), HYPOTENSION (94/59), AND SLIGHTLY ELEVATED PTT OF 45 WHICH WAS AN INCREASE FROM 41/42. THE PT ALSO EXPERIENCED A NON-HEALING WOUND SINCE MID-JUNE WITH SERIOUS FLUID OOZING FROM THE POCKET SITE. A POCKET REVISION WAS DONE TO CLEAN OUT AND CLOSE THE WOUND. CULTURES OF THE SITE WERE NEGATIVE. FOLLOWING THE REVISION, THE PT CONTINUED TO EXPERIENCE "HEMETINGED" DRAINAGE FROM THE SUTURE PUNCTURE OPENINGS. THE HCP HAD HELD BLOOD PRESSURE MEDICATION AND CONSIDERED AN ADDITIONAL PUMP POCKET REVISION. THE PT HAD SKIN ALLERGY TESTING, BUT THE RESULTS WERE NOT REPORTED. THE PT WAS NOT ON OTHER ANTICOAGULANTS. THE HCP REPORTED NO NEUROLOGICAL CHANGES. NO FURTHER OUTCOME WAS REPORTED. 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 LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention PROGRAMMER MODEL PROGRAMMER LOT# UNK| IMPLANTED| EXPLANTED| CATHETER MODEL CATHETER LOT# UNK