BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE EXTERNAL NEUROSTIMULATOR

    MDR report key: 3790735 · Received May 5, 2014

    Report

    Report Number
    3007566237-2014-01245
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 355531, LOT# N444706, PRODUCT TYPE SCREENING DEVICE; PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE MULTI-LEAD TRIALING CABLE L/N (B)(4) FOUND NO ANOMALY. THE CABLE WAS CONNECTED TO AN EXTERNAL NEUROSTIMULATOR WITH TWO KNOWN GOOD LEADS. THE ELECTRODES OF THE LEADS WERE PLACED IN A 0.9% SALINE SOLUTION. IMPEDANCES WERE MEASURED AND WERE GOOD ON EVERY ELECTRODE PAIR. CONTINUITY WAS SHOWN AS ACCEPTABLE.

    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 THE CALLER WAS IN A STIMULATION TRIAL AND WAS GETTING ¿XXX¿ FOR ALL THE ELECTRODE IMPEDANCE VALUES. IT WAS NOTED THAT THE CALLER HAD TRIED MULTIPLE TIMES. AFTER REPLACING THE BATTERY IN THE EXTERNAL NEUROSTIMULATOR (ENS) THE MANUFACTURER REPRESENTATIVE WAS ABLE TO RUN VALUES BUT NOTED THAT THEY WERE GETTING GREATER THAN 10K OHMS. THE CALLER COULD NOT RUN HIGHER THAN 0.7V BECAUSE THE PATIENT APPEARED TO BE SENSITIVE TO STIMULATION. THE CALLER NOTED THEY HAD TRIED REPLACING THE MULTI-LEAD TRIALING CABLE (MLTC) TWICE, CLEANED OUT THE MLTC AND LEAD ETC. THE CALLER NOTED THAT THEY SWITCHED OUT THE LEADS (THE ONE THAT WAS IN THE 8-15 INTO THE 0-7) AND WAS ABLE TO GET VALUES IN THE 5,8 AND 9000S. THE CALLER NOTED THAT THEY TESTED STIMULATION ON VARIOUS CONTACTS (11,12,13,14) AND WAS ABLE TO GET STIMULATION FOR THE PATIENT THOUGH THE IMPEDANCES WERE VERY HIGH. IT WAS REVIEWED THAT THE FACT THE PATIENT WAS ABLE TO FEEL STIMULATION/THERAPY BEYOND THE HIGH IMPEDANCES WAS POSITIVE AND THAT THE IMPEDANCE VALUES THEY WERE SEEING MAY JUST BE THE RESULT OF TEMPORARY HIGH IMPEDANCE. IT WAS LATER REPORTED THAT THERE WAS AN IMPEDANCE ISSUE OF A ??? ERROR. IT WAS NOTED THAT ALL IMPEDANCES SHOWED ¿XXX.¿ THE EVENT OCCURRED DURING THE PROCEDURE. IT WAS NOTED THAT ACTIONS REQUIRED AS A RESULT OF THE EVENT WAS THAT A DIFFERENT MLTC WAS USED. THE PRODUCT STATUS OF THE MLTC WAS WILL BE RETURNED. DIAGNOSTICS OR TROUBLESHOOTING INCLUDED IMPEDANCE TESTING. THE ISSUE WAS NOT RESOLVED. THE CAUSE OF ISSUE WAS NOT DETERMINED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT¿S STATUS AT THE TIME OF THE REPORT WAS ALIVE WITH NO INJURY. IT WAS LATER REPORTED THAT THE CAUSE OF ISSUE WAS NOT DETERMINED. THE PATIENT CONTINUED WITH THE TRIAL AND AS OF (B)(6) 2014 THE PATIENT HAD ¿GREAT¿ RESULTS AND WAS LOOKING FORWARD TO IMPLANT. IT WAS NOTED THAT THE MLTC WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267535 RESTORE EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37022

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR