BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL NEUROSTIMULATOR, UNKNOWN

    MDR report key: 3233113 · Received July 18, 2013

    Report

    Report Number
    3007566237-2013-02395
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE 3888-28 LEAD FOUND NO ANOMALY. ANALYSIS OF THE 3888-33 LEAD FOUND NO ANOMALY. ANALYSIS OF THE UNKNOWN ANCHORS FOUND NO ANOMALY. NO DEVICE ANALYSIS WAS PERFORMED ON THE UNKNOWN SETSCREWS; THE COMPONENT MET RISK BASED CRITERIA.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3888-28, LOT# 0207089114, IMPLANTED: 2013-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3888-33, LOT# 0207088429, IMPLANTED: 2013-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3888-28, LOT# 0207089114, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-33, LOT# 0207088429, IMPLANTED: (B)(6)2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-39, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3550-39, PRODUCT TYPE: ACCESSORY. PRODUCT ID: NEU_SET_SCREW, PRODUCT TYPE: ACCESSORY. PRODUCT ID: NEU_SET_SCREW, PRODUCT TYPE: ACCESSORY. 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO LEADS WERE IMPLANTED AND WHEN INSERTED INTO THE MULTI-LEAD TRIALING CABLE BOTH LEADS GAVE HIGH IMPEDANCES OF OVER 10 ,000. IT WAS NOTED THAT BOTH LEADS WERE REPLACED FOR NEW ONES. IT WAS NOTED THAT THERE WAS NO HARM OR INJURY AND THAT WITH THE NEW ELECTRODES THE PATIENT RECEIVED GOOD STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333419 EXTERNAL NEUROSTIMULATOR, UNKNOWN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR