BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4214071 · Received October 30, 2014

    Report

    Report Number
    3007566237-2014-03164
    Event Type
    Injury
    Date Received
    October 30, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, SERIAL# PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A THIRD ADVERSE EVENT WHERE THEY NEEDED TO REMOVE AN IMPLANTABLE NEUROSTIMULATOR (INS) DUE TO INFECTION. THE HEALTH CARE PROVIDER (HCP) DID NOT HAVE THE SERIAL NUMBERS FOR THE PATIENT¿S DEVICE ON HAND AND WAS NOT COMFORTABLE PROVIDING THE PATIENT NAMES. THE HCP MIGHT BE ABLE TO FIND THE SERIAL NUMBERS BUT IT WOULD TAKE SOME TIME. NO PATIENT INFORMATION OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP WILL BE CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. REFER TO MANUFACTURER'S REPORT # 3007566237-2014-02725 FOR THE HCP'S INITIAL REPORT OF SEVERE SIDE EFFECTS/COMPLICATIONS WITH SNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695491 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention