BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2130410 · Received June 13, 2011

    Report

    Report Number
    3004209178-2011-04336
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    September 15, 2010
    Report Date
    May 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEAD HAD FRACTURED AND A REVISION WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention IMPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT# V328412| PROGRAMMER: MODEL 3037, LOT# NJD093937N| EXPLANTED:| EXPLANTED: