BEUDAMED
    FDA Adverse Event Other Summary report: N

    DBS

    MDR report key: 2803287 · Received February 1, 2006

    Report

    Report Number
    2649622-2006-01735
    Event Type
    Other
    Date Received
    February 1, 2006
    Date of Event
    January 19, 2006
    Report Date
    January 20, 2006
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS
    Product Code
    MHY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HCP REPORTS IPG LEAD EXPLANT DUE TO INFECTION. THE PATIENT PRESENTED WITH SIGNS OF INFECTION INCLUDING SWELLING AND REDNESS ON THE SKIN, JUST OVER THE LEAD, ON THE RIGHT SIDE OF THE HEAD. NO CULTURE INFORMATION WAS REPORTED, HOWEVER, THE PATIENT IS BEING TREATED WITH IV ANTIBIOTICS FOR 1 MONTH AND UNDERWENT LEAD EXPLANT. THERE IS NO PLAN AT THIS TIME TO REIMPLANT THE LEAD. THE DEVICE WAS EXPLANTED, BUT NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DBS LEAD MHY MEDTRONIC PUERTO RICO OPERATIONS 3387 J0220057V

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT # NHU079298V| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT # J0322212V| EXTENSION: MODEL 7482, LOT # NHU077287V| LOT # NFD101220H| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7428| EXPLANTED: