BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3874 1X8 COMPACT TRIAL LEAD

    MDR report key: 3143483 · Received June 3, 2013

    Report

    Report Number
    3007566237-2013-01842
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_ENS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE EXTERNAL NEUROSTIMULATOR 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

    ANALYSIS OF THE TRIAL LEAD FOUND THAT THE DISTAL END ELECTRODE PULLED OUT OR PULLED OFF. ANALYSIS OF THE STYLET ACCESSORY FOUND THAT THE WIRE HAD BENT. IT WAS STATED THAT THE #0 ELECTRODE WAS TORN OFF AND NOT RECEIVED. IT WAS NOTED THAT CONTINUITY WAS ACCEPTABLE ON CIRCUITS #0-6.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TRIAL LEAD WAS DAMAGED DURING THE IMPLANT PROCEDURE. THE PHYSICIAN WAS PLACING PERCUTANEOUS TRAILING LEAD AND AS THEY WERE REPOSITIONING THE LEAD, AN ELECTRODE GOT CAUGHT ON THE NEEDLE AND FELL OFF INTO THE EPIDURAL SPACE. THREE DAYS LATER IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS REMOVING THE LEAD FROM THE EPIDURAL SPACE, THE LAST ELECTRODE "GOT CAUGHT UP". IT WAS STATED THAT "THIS HAPPENS A FAIR AMOUNT" FOR THE PHYSICIAN. IT WAS STATED THAT THE PHYSICIAN TURNED THE NEEDLE TO SEE IF SHE COULD "FREE IT UP: AND ENDED UP CUTTING THE TUP OF THE LEAD OFF. ONE ELECTRODE WAS LEFT IN THE PATIENT IN THE MUSCLE/ ADIPOSE TISSUE. IT WAS STATED THAT THE PHYSICIAN PLACED A DIFFERENT LEAD DOWN A LEVEL FOR THE TRIAL. IT WAS NOTED THAT THE PATIENT WAS GOING BACK TO SEE THE PHYSICIAN THE NEXT DAY FOR THE END OF THE TRIAL AND PULLING THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243677 3874 1X8 COMPACT TRIAL LEAD STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC NEUROMODULATION 3874

    Patients

    Seq Age Sex Outcome Treatment
    1 Other