BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1851116 · Received September 30, 2010

    Report

    Report Number
    3004209178-2010-07497
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 3, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD AN ACUTE INFECTION AT THE SITE OF THE LEAD. FLOXACILLIN WAS GIVEN FOR 4 WEEKS WITHOUT EFFECT. ON SURGICAL INSPECTION AT EXPLANT, EVIDENCE OF INFECTION WAS NOTED WITH THE LEAD. THE LEAD AND NEUROSTIMULATOR WERE REMOVED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention LEAD: MODEL 3093, LOT# UNK| EXPLANTED:| IMPLANTED: