BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2901737 · Received January 8, 2013

    Report

    Report Number
    3004209178-2013-00306
    Event Type
    Injury
    Date Received
    January 8, 2013
    Report Date
    December 19, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# VA002AM, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT LIKE HER CHEST, NECK AND ARMS WERE COLD AND SHE WAS SHIVERING. THE PATIENT WAS UNSURE IF THAT COULD BE RELATED TO STIMULATION. THE REPORTER STATED THAT THE PATIENT WAS ON VESICARE, AN ANTIBIOTIC, AND WAS ON BLADDER TRAINING. IT WAS NOTED THAT THE PATIENT ALSO SAW HER HEALTHCARE PROVIDER (HCP) THE PREVIOUS THURSDAY AND WAS TOLD SHE MAY HAVE A LOW GRADE URINARY TRACT INFECTION (UTI). IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8880 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention