BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2231099 · Received August 26, 2011

    Report

    Report Number
    3007566237-2011-06947
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    January 1, 2011
    Report Date
    August 9, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CATHETER BREAK AT THE DISTAL SEGMENT WAS REPORTED. CAUSE WAS UNK. THE DRUG INFUSED WAS MORPHINE AND COMPOUNDED BACLOFEN. THE CATHETER WAS REPLACED. PT WAS HOSPITALIZED AND SUSTAINED NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N128040001| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# N084309017