BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 2100354 · Received May 13, 2011

    Report

    Report Number
    3007566237-2011-03504
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 25, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THERE WAS AN ISSUE WITH THE LEAD. DURING AN IMPLANT, THE PHYSICIAN TRIED TO UNSCREW THE SINGLE SCREW HOLDING THE LEAD CAP THEN THE SCREW POPPED OUT AND THE DISTAL END OF THE LEAD WAS STUCK AND HARD TO REMOVE UNTIL HE WIGGLED IT OUT. WHEN THE LEAD CAME OUT, THERE WAS OBVIOUSLY ONE WIRE STICKING OUT AND BROKEN FROM THE CONTACT. SINCE IT WOULD NOT BE POSSIBLE TO INSERT THE DISTAL END INTO THE EXTENSION CONNECTOR WITH THE BROKEN WIRE, THE PHYSICIAN DECIDED TO CUT THE LAST CONTACT WITH THE BROKEN WIRE AND INSERT ONLY 3 CONTACTS INTO THE CONNECTOR. HE TOOK CARE TO ALIGN THE CONTACTS AND TIGHTENED EACH SCREW WITH THE TORQUE WRENCH. IMPEDENCE CHECK AFTER INSERTION OF EXTENSION INTO THE IPG SHOWED ONLY CONTACT #11 WITH OPEN CIRCUIT AND THE OTHER 7 CONTACTS HAD NORMAL IMPEDENCE. IMPLANTATION OF THE IPG WAS COMPLETED WITH THE IMPEDENCE DATA PRINTED OUT FOR PATIENT CHART AND FOLLOW UP AFTER 6 WEEKS OF RECOVERY. CAUSE OF PROBLEM - HEX WRENCH WITH LEAD KIT WAS USED IN TIGHTENING THE SET SCREW OF THE LEAD CAP. THIS WAS THE PHYSICIAN'S FIRST TIME WITH A SLIGHTLY TWISTED SET SCREW AND OVERTIGHTENED LEAD CONTACT. THE FORCING OUT OF THE DISTAL CONTACT END IS LIKELY THE CAUSE OF THE BROKEN WIRE. OUTCOME - PATIENT IN RECOVERY FOR SEVERAL WEEKS BEFORE BEING PROGRAMMED AND THERE ARE 7 ELECTRODES AVAILABLE FOR USE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SPINAL CORD STIMULATOR LGW MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN CONVERSION TYPE: MODEL LEADN| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LOT# UNKNOWN| LEAD: MODEL 3982, LOT# UNKNOWN