BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 5104103 · Received September 25, 2015

    Report

    Report Number
    3004209178-2015-18711
    Event Type
    Injury
    Date Received
    September 25, 2015
    Report Date
    August 31, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3889-28, LOT# V001614, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS CONSIDERED A POTENTIAL REPLACEMENT PATIENT (PRP) AND WAS CALLED TO FACILITATE SCHEDULING OF A FOLLOW-UP APPOINTMENT WITH HEALTHCARE PROVIDER. SHE HAD THE DEVICE REMOVED YEARS AGO BECAUSE IT WASN'T DOING ANY GOOD. PATIENT WAS BRIEF AND PROVIDED NO FURTHER DETAILS. THE NEUROSTIMULATOR WAS FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634842 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Required Intervention