BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2032370 · Received March 28, 2011

    Report

    Report Number
    3004209178-2011-02335
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S LEAD BROKE. THE PT APPROPRIATE STIMULATION ON THE DAY OF IMPLANT. THE DEVICE WAS REMOVED AND NOT REPLACED. THE PT RECOVERED WITHOUT SEQUELA.

    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 65 YR Required Intervention EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD114624N| LEAD: MODEL 3889BLUE_LEAD, LOT# V645571