BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4811444 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-10083
    Event Type
    Injury
    Date Received
    June 2, 2015
    Report Date
    May 13, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V649846, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED TWICE IN THE YEAR PRIOR TO REPORT. SHE WAS REPORTEDLY HOSPITALIZED 10 MONTHS PRIOR TO REPORT FOR AN UNDISCLOSED REASON AS WELL AS SIX MONTHS PRIOR TO REPORT FOR CERVICAL OSIOMILITUS (AN INFECTION IN THE VERTEBRAE IN HER NECK). THEY WERE THINKING OF REMOVING A TITANIUM ROD AND THE MEDTRONIC DEVICE IN CASE THE INFECTION WAS IN THOSE LOCATIONS. EACH TIME THAT THE PATIENT WAS HOSPITALIZED SHE HAD TO TELL THEM THAT SHE COULD NOT HAVE AN MRI. THEY DID A NUCLEAR BONE SCAN INSTEAD. IT WAS REPORTED THAT THE PATIENT WAS LAST SEEN BY HER PHYSICIAN IN (B)(6) 2014. NO INTERVENTIONS OR OUTCOMES WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355520 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization