BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2172345 · Received June 23, 2011

    Report

    Report Number
    3004209178-2011-04748
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    January 1, 2010
    Report Date
    May 27, 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
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT SUFFERED A FALL ABOUT A YEAR AGO AND SINCE THE FALL HER STIMULATION "FEELS DIFFERENT." SHE ALSO EXPERIENCED A SHOCKING OR JOLTING SENSATION THAT SHE DESCRIBED AS A "ZING." THE PATIENT ALSO NOTED THAT HER BOWEL MOVEMENTS CAN BE DIFFICULT. THE STIMULATION CHANGES WERE RANDOM AND OCCURRED ANY TIME OF DAY OR NIGHT AND IN ANY PHYSICAL POSITION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR IMPLANTED:| LEAD: MODEL 3889, LOT# J0427676V| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 3095, LOT# NAH016115V| EXPLANTED:| PROGRAMMER: MODEL 3031A, LOT# NGM014370P