BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1895274 · Received November 8, 2010

    Report

    Report Number
    3004209178-2010-09068
    Event Type
    Injury
    Date Received
    November 8, 2010
    Date of Event
    May 1, 2010
    Report Date
    October 19, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S DEVICE WAS REMOVED DUE TO THE PT FEELING THE DEVICE WAS "NOT WORKING MUCH FOR HER." IT WAS STATED THE PT STILL HAD OVERACTIVE BLADDER SYMPTOMS, BUT SHE HAD RECOVERED FULLY FROM THE DEVICE REMOVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention LEAD: MODEL 3889, LOT# V016209| IMPLANTED:| EXTENSION: MODEL 3095, LOT# NAH027062V| IMPLANTED:| EXPLANTED:| EXPLANTED: