BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1823483 · Received August 25, 2010

    Report

    Report Number
    3007566237-2010-06419
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 27, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    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

    IT WAS REPORTED THE PATIENT HAD A BLISTER AT THE SURGICAL SITE. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2010. THE ENTIRE SYSTEM WAS REMOVED ON (B)(6) 2010 DUE TO AN INFECTION IN THE PUMP POCKET. THE DRUG USED IN THE PUMP WAS LIORESAL 2000 MCG/ML AT A DOSE OF 215 MCG/DAY. THE PATIENT WAS MANAGED WITH ORAL BACLOFEN AND VALIUM. THE PATIENT WAS DOING WELL FOLLOWING EXPLANT. THE PLAN IS TO RE-INSERT A NEW PUMP IN APPROXIMATELY 6 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER: MODEL 8709SC, LOT# N246159009| IMPLANTED:| EXPLANTED: