BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3007566237-2012-02313

    MDR report key: 2760124 · Received September 26, 2012

    Report

    Report Number
    3007566237-2012-02313
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    August 27, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A DIFFICULTY DURING IMPLANT ADVANCING THE STYLET INTO THE LEAD. THIS OCCURRED WHEN THE TIP OF THE STYLET WAS BEING ADVANCED THROUGH THE PORTION OF THE LEAD WITH THE ELECTRODES. THE PHYSICIAN USED HEMOSTATS AND WAS ABLE TO ADVANCE THE STYLET INTO THE LEAD. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE STYLETS WERE DIFFICULT TO ADVANCE BUT EVENTUALLY WENT IN AND THE LEADS WORKED NORMALLY. DIPPING THE STYLETS IN WATER WAS TRIED BUT IT DID NOT MAKE MUCH DIFFERENCE. THE PATIENT DID NOT HAVE AN ADVERSE OUTCOME RELATED TO THIS EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1