BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1843592 · Received September 22, 2010

    Report

    Report Number
    3004209178-2010-07186
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 24, 2010
    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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PT HAD IMPLANTABLE NEURO STIMULATOR AND LEAD REPLACED. PT STATED LEAD WAS KINKED. IT WAS ALSO REPORTED PT COULD NOT FEEL STIMULATION FOLLOWING THE IMPLANT. PT STATED SHE WAS NOT ABLE TO MAKE IT TO THE BATHROOM ON TIME AND HAD NOT USED HER PT PROGRAMMER SINCE THE SURGERY. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND WILL BE PROVIDED WHEN AVAILABLE.

    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 57 YR Required Intervention IMPLANTABLE NEURO STIMULATOR:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT# V503941| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3093, LOT# V177458| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD078683N| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD111367N| EXPLANTED:| IMPLANTED:| IMPLANTED:| MODEL 3058, LOT# NJY153638H