BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2940252 · Received February 2, 2013

    Report

    Report Number
    3004209178-2013-01238
    Event Type
    Injury
    Date Received
    February 2, 2013
    Report Date
    January 21, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-33, LOT# V289339, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD THE DEVICE REMOVED IN (B)(6) 2012. THE PATIENT'S BLADDER CONTROL WASN'T AN ISSUE. THE PATIENT'S HEALTH CARE PROVIDER (HCP) DETERMINED SLEEP APNEA WAS WAKING THE PATIENT UP. THE PATIENT HAD OTHER MEDICAL ISSUES THAT REQUIRED AN MRI, AND THE HCP DECIDED TO REMOVE THE IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45830 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention