BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3040034 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-04835
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-33, LOT # VA00L3U, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED. IT WAS UNCLEAR IF THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT WITH THIS INS OR HER PREVIOUS INS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    SUPPLEMENTAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH HER DEVICE/THERAPY, BUT WAS WORKING WITH HER DOCTOR OR MANUFACTURER REPRESENTATIVE. APPOINTMENT DATES OF (B)(6) 2013 WERE NOTED AND THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2013. IT WAS NOTED THAT THE PATIENT'S UNIT CAME OUT OF THE POCKET. IT WAS UNCLEAR WHETHER IT WAS THE PATIENT'S PREVIOUS DEVICE (PLEASE REFER TO MFT. REPORT # 3004209178-2013-04834) OR THIS DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143471 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention