BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 7323336 · Received March 8, 2018

    Report

    Report Number
    3004209178-2018-04646
    Event Type
    Injury
    Date Received
    March 8, 2018
    Date of Event
    February 26, 2018
    Report Date
    March 8, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR PATIENT REPORTED SWOLLEN SCAR AT THE IMPLANT SITE AND WAS WONDERING IF IT WAS AN INFECTION. NO FURTHER COMPLICATIONS WERE NOTED OR ANTICIPATED REFER TO (B)(4) FOR DETAILS PERTAINING TO RELATED EVENT: LOE/POCKET PAIN SINCE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169246 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention