BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2212650 · Received August 11, 2011

    Report

    Report Number
    3007566237-2011-06239
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 15, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CATHETER FRACTURE WAS REPORTED AND A REVISION WAS INDICATED ON (B)(6) 2011. PT HAD NOT BEEN GETTING DRUG FOR TWO DAYS AND EXPERIENCED WITHDRAWAL. HCP (HEALTH CARE PROVIDER) WANTED TO DECREASE THE DOSE THE DAILY DOSE TO 8MG/DAY. THE DRUG INFUSED WAS MORPHINE 35MG/ML AT 16MG/DAY. A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    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 Required Intervention EXPLANTED:| CATHETER: MODEL CATHETER, LOT# UNK| IMPLANTED: