BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2141126 · Received June 22, 2011

    Report

    Report Number
    3004209178-2011-04679
    Event Type
    Injury
    Date Received
    June 22, 2011
    Report Date
    May 25, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DIFFICULTY FILLING THE RESERVOIR. THEY WERE ABLE TO ASPIRATE THE RESERVOIR OF APPROX 1ML OF THE DRUG. THEY WERE UNSURE WHETHER THE PUMP WAS EMPTY. THEY WERE UNABLE TO FILL IT TO 40ML AND HAD SIGNIFICANT RESISTANCE AT 30ML. A SIMILAR SITUATION WAS EXPERIENCED IN A PREVIOUS REFILL WHERE IT WAS EXCEPTIONALLY DIFFICULT BUT THEY COULD FILL IT TILL 40ML. PT COMPLAINED OF INCREASED PAIN APPROX 3 DAYS AFTER THE REFILL WITH RETURN OF SYMPTOMS, ESPECIALLY INCREASE IN BASELINE PAIN. THERE WERE NO ALARMS. THE DRUGS INFUSED IN THE PUMP INCLUDED FENTANYL CONCENTRATION 400MCG/ML, DOSE 1200MCG/DAY AND BUPIVACAINE (MARCAINE) CONCENTRATION 36MG/ML. THE PUMP WAS REPLACED. ONCE EXPLANTED, APPROX 1ML OF THE DRUG COULD BE ASPIRATED FROM THE PUMP. ADD'L INFO 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
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention CATHETER: MODEL 8711, LOT# J11588R40.| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8711, LOT# J11588R40