BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERSTIM

    MDR report key: 752884 · Received August 15, 2006

    Report

    Report Number
    3004209178-2006-01362
    Event Type
    Other
    Date Received
    August 15, 2006
    Date of Event
    December 2, 2003
    Report Date
    July 31, 2006
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., MEDREL
    Product Code
    EZW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO MEDTRONIC INC. FOR EVALUATION.

    Description of Event or Problem · 1

    THE HCP REPORTED THAT IN 2003, THE PATIENT DEVELOPED SWELLING, DRAINAGE, AND PAIN OF THE NEUROSTIMULATOR DEVICE POCKET SITE. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS AND THE DEVICE SYSTEM EXPLANTED. THE INFECTION IS REPORTED AS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM IPG EZW MEDTRONIC PUERTO RICO OPERATIONS CO., MEDREL 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other LOT# L91533| IMPLANTED:| LEAD MODEL 3886| IMPLANTABLE PULSE GENERATOR| MODEL 3023 LOT# NBV110739H| EXPLANTED:| IMPLANTED:| EXPLANTED: