BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3002656 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03669
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V509981, IMPLANTED: (B)(6) 2010, EXPLANTED: UNK. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT DOWN HER LEG THE SAME SIDE AS THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT WANTED TO HAVE THE DEVICE REMOVED. IT WAS SUGGESTED TO TURN THE DEVICE OFF TO SEE IF THAT WOULD RELIEVE THE DISCOMFORT. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD HER DEVICE EXPLANTED DUE TO A SEPARATE BACK ISSUE, IN WHICH SHE NEEDED A MAGNETIC RESONANCE IMAGING (MRI) SCAN FOR. THE PATIENT OUTCOME WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105354 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention