BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3050519 · Received April 10, 2013

    Report

    Report Number
    3007566237-2013-01189
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    October 1, 2012
    Report Date
    September 12, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DATE THE INFECTION WAS FOUND WAS UNKNOWN. THE LOCATION OF THE INFECTION WAS AROUND THE PUMP, BUT THE CAUSE WAS UNKNOWN. THE PATIENT¿S SKIN AROUND THE PUMP WAS RED AND WARM TO THE TOUCH. THE PUMP WAS EXPLANTED (B)(6) 2013; ANTIBIOTICS WERE GIVEN TO THE PATIENT FOR 1 WEEK, AND THE INFECTION CLEARED WITHIN THAT WEEK. A NEW PUMP WAS PLACED ON (B)(6) 2013. THE DILAUDID DOSE WAS 10 MG/ML AT 0.701 MG/DAY. IT WAS UNKNOWN IF THE DEVICE WOULD BE RETURNED. THE PATIENT WAS DOING WELL, THE INFECTION WAS CLEAR PRIOR TO NEW PUMP PLACEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP HAD BEEN IMPLANTED IN THE PATIENT'S BUTTOCKS AND THAT HE "SPENT FIVE MONTHS LAYING," AND "THEY COULDN'T FIGURE OUT WHAT WAS WRONG" WITH THE PATIENT. IT WAS NOTED THAT THE PUMP "PUSHED ITS WAY OUT," "IT ERODED ITS WAY OUT OF" THE PATIENT'S SKIN AND "IT GOT INFECTED BECAUSE OF THAT." THE DEVICE "HAD" TO BE TAKEN OUT "BECAUSE THE GUY LEFT IN FIVE MONTHS AND IT LEFT IT INFECTED FOR FIVE MONTHS." IT WAS UNCLEAR WHAT DRUG OR DRUGS THE DEVICE SYSTEM WAS USED TO INFUSE, THE REPORTER STATED "I DON'T KNOW WHAT THEY HELL THERE WERE USING, MORPHINE OR WHAT'S THE OTHER ONE?" "THEY WERE USING DILAUDID, I THINK," "I THINK IT WAS JUST DILAUDID," "HOW DO YOU SAY INFUMORPHINE OR WHATEVER." 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
    152403 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention