BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 2940421 · Received February 3, 2013

    Report

    Report Number
    3007566237-2013-00350
    Event Type
    Injury
    Date Received
    February 3, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 11, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PRIMARY SITE OF THE INFECTION WAS THE LEAD TRACK AND CULTURES THAT WERE TAKEN GREW (B)(6). PATIENT SYMPTOMS OF REDNESS, DRAINAGE, AND PAIN WERE REPORTED. TREATMENT FOR THE PATIENT INCLUDED ORAL ANTIBIOTICS AND EXPLANT OF THE ENTIRE TRIAL NEUROSTIMULATOR SYSTEM. THE PATIENT OUTCOME WAS REPORTED AS "UNKNOWN". IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INFECTION. SYMPTOMS INCLUDED A FEVER AND A "DRYING ITCH FROM THE SITES." "THE SITES" LIKELY REFERRED TO DEVICE IMPLANT SITES. IT WAS NOTED THAT THE PATIENT'S HEALTH CARE PROVIDER DIDN'T MENTION WHERE THE INFECTION STARTED. THE REPORTER STATED THAT THE DEVICE TRIAL STARTED ON (B)(6) 2012 AND AFTER TWO WEEKS THE PATIENT HAD TO HAVE IT REMOVED DUE TO THE INFECTION. IT WAS REPORTED THAT THE TRIAL "WORKED GREAT" THE FIRST WEEK. THE REPORTER STATED THAT ONCE THE PATIENT HEALED UP SHE HOPED TO GET "THE SECOND ONE" PUT BACK IN. THE PATIENT WAS GIVEN A SAMPLE OF THE LEAD WIRE SO AN ALLERGIST COULD MAKE SURE SHE DIDN'T HAVE AN ALLERGIC REACTION TO IT. IT WAS NOTED THAT THE PATIENT ALSO WANTED A SAMPLE OF THE IMPLANTABLE NEUROSTIMULATOR MATERIAL FOR THE ALLERGIST. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45720 EXTERNAL NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention