BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 3173682 · Received June 17, 2013

    Report

    Report Number
    3007566237-2013-02005
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 28, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# VA080TE, IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE STAGE 1 TRIAL PATIENT WAS ADMITTED TO THE HOSPITAL FOR AN INFECTION AT THE EXIT SITE OF THE PERCUTANEOUS EXTENSION. IT WAS STATED THE DOCTOR WAS GOING TO TREAT THE INFECTION AND HAD PLANS TO GO ON TO THE FULL IMPLANT WHEN THE INFECTION CLEARS. IT WAS STATED THE INFECTION HAD NOT AFFECTED THE FUTURE IMPLANT SITE. INFORMATION RECEIVED THE FOLLOWING DAY INDICATED THE PATIENT HAD BEEN DISCHARGED FROM THE HOSPITAL WITH ANTIBIOTICS. THE INFECTION WAS NOT CONFIRMED. THE DOCTOR DID NOT SEE AN ACTIVE INFECTION. THE PATIENT WAS IN RECOVERY WITH ANTIBIOTICS IN CASE THE INFECTION DID EXIST, BUT ¿WASN¿T OBVIOUS.¿ A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    FOLLOW-UP INFORMATION WAS RECEIVED WHICH REPORTED THAT THE PATIENT WENT ON TO FULL IMPLANT ON (B)(6) 2013. IT WAS UNCLEAR IF THE INFECTION RESOLVED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT WAS GIVEN ANTIBIOTICS WITH NO CULTURE AFTER THE FIRST INFECTION BETWEEN STAGE ONE AND STAGE TWO. IT WAS NOTED THE ON-CALL DOCTOR THOUGHT THE INCISION WAS INFECTED BUT IT WAS LATER DETERMINED BY THE PATIENT¿S DOCTOR TO NOT BE INFECTED BY LOOKING AT IT. IT WAS STATED ANTIBIOTICS WERE PRESCRIBED JUST IN CASE. REFERENCE MANUFACTURER REPORT #3004209178-2013-11813 FOR INFORMATION FOLLOWING THE STAGE TWO IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273044 EXTERNAL NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R