BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2831362 · Received November 14, 2012

    Report

    Report Number
    3007566237-2012-02706
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 16, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED "COLON BLOCKAGE" AND HIGH BLOOD SUGAR LEVELS 9 DAYS AFTER STARTING THE TRIAL PHASE OF THE NEUROSTIMULATOR THERAPY. THE PATIENT STATED IT WAS DUE TO ISSUES FROM THE ANESTHESIA AND THEIR DIABETES. THE PATIENT DID GO TO THE EMERGENCY ROOM FOR THE EVENT. THE PATIENT SUBSEQUENTLY WENT ON TO THE PERMANENT IMPLANT OF THE IMPLANTABLE NEUROSTIMULATOR (INS). AS OF (B)(4), 2012 THAT PATIENT FELT MUCH BETTER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A REACTION TO THE ANESTHESIA DURING SURGERY. IT WAS UNCLEAR IF THIS MEANT THE TRIAL OR PERMANENT IMPLANT SURGERY. THE DEVICE WAS WORKING AND IMPROVING HER SYMPTOMS. THE PATIENT WAS DOING JUST FINE AND HAD NO FURTHER EFFECTS OF THE REACTION WITH THE ANESTHESIA. LATER THAT DAY IT WAS REPORTED THAT ALL WAS RESOLVED AND THE PATIENT HAD NO ISSUES SINCE THEN. THE PATIENT OUTCOME WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention