BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTAD TRIAL LEAD

    MDR report key: 3092040 · Received May 3, 2013

    Report

    Report Number
    6000153-2013-00088
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    NEURO - VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS FOR THE LEAD REVEALED A PROCEDURAL NON-CONFORMANCE. CONDUCTOR #0 WAS BROKEN (OVERSTRESSED/DAMAGED) 0.8CM FROM THE DISTAL END. FINAL DEVICE ANALYSIS FOR THE STYLET REVEALED A BENT WIRE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_STYLET_ACC, PRODUCT TYPE ACCESSORY. (B)(4).

    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 LEAD TIP FRACTURED DURING THE PROCEDURE AFTER THE IMPLANTING PHYSICIAN ACCIDENTLY ADVANCED THE INTRODUCER NEEDLE THROUGH SOFT TISSUE WITH THE LEAD TIP PROTRUDING THROUGH THE TIP OF THE NEEDLE. THE PHYSICIAN NOTICED THE FRACTURE OF THE LEAD AND REMOVED THE LEAD AND INTRODUCER NEEDLE COMPLETELY. IT WAS REPORTED THAT THE LEAD WAS NEVER IMPLANTED IN THE PATIENT AND WAS REPLACED WITH A NEW ONE. IT WAS NOTED THAT THERE WERE NO PATIENT SYMPTOMS RELATED TO THE EVENT AND THE PATIENT SUFFERED NO INJURY OR ADVERSE EVENT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194808 OCTAD TRIAL LEAD STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW NEURO - VILLALBA 387445 VA07W1C

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR