BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2231107 · Received August 26, 2011

    Report

    Report Number
    3007566237-2011-06960
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    January 1, 2011
    Report Date
    August 10, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING ADEQUATE PAIN RELIEF. THE DRUG INFUSED WAS DILAUDID 40MG/ML, 5.9 MG. PHYSICIAN STATED THAT THE REDUCTION IN EFFICACY WAS RELATED TO ERI (ELECTIVE REPLACEMENT INDICATOR). DURING THE REVISION THE TIP OF THE CATHETER WAS PLACED AT T12, ACCORDING TO SURGEON THAT IS RIGHT ABOUT WHERE HE NOTICED A CATHETER FRACTURE. THE WHOLE SYSTEM WAS REPLACED. POST REPLACEMENT THE PATIENT WAS REPORTED AS DOING FINE. DAILY DOSE WAS REDUCED SIGNIFICANTLY: MINIMUM RATE OF .24 BECAUSE AT LOWEST DOSE WITH 40 MG/ML CONCENTRATION OF 1.92 WAS TOO MUCH FOR THE PATIENT PER THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention CATHETER: MODEL 8709, LOT# J11921R01| IMPLANTED:| EXPLANTED: