BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN EXTERNAL NEUROSTIMULATOR

    MDR report key: 3113705 · Received May 15, 2013

    Report

    Report Number
    3007566237-2013-01621
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD FOUND THAT THE DISTAL END CONDUCTOR WAS BROKEN. IT WAS FOUND THE #0 CONDUCTOR WAS BROKEN AT THE DISTAL EDGE OF THE #1 ELECTRODE SLEEVE. ANALYSIS OF THE STYLET FOUND NO SIGNIFICANT ANOMALY; IT WAS FOUND THE WIRE WAS BENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), PRODUCT TYPE LEAD; PRODUCT ID NEU_STYLET_ACC, PRODUCT TYPE ACCESSORY. (B)(4).ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE LEAD APPEARED TO HAVE BEEN VISIBLY FRACTURED AT THE DISTAL TIP. WHEN IMPLANTED, IMPEDANCE TESTING RESULTED IN OUT OF RANGE IMPEDANCES. THE LEAD WAS REPLACED WITH ANOTHER LEAD TO CONTINUE THE PROCEDURE. THE PATIENT¿S STATUS AT TIME OF REPORT WAS NOTED AS NO INJURY OR ADVERSE EVENT. THERE WERE NO PATIENT SYMPTOMS OR INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215582 UNKNOWN EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR