BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4122582 · Received September 26, 2014

    Report

    Report Number
    3007566237-2014-02713
    Event Type
    Injury
    Date Received
    September 26, 2014
    Report Date
    September 3, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 97791, LOT# UNKNOWN, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 977A290, LOT# UNKNOWN, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (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

    (B)(4). DEVICE EVALUATION: ANALYSIS OF LEAD ONE FOUND ¿THE #7 CONDUCTOR WAS BROKEN AT THE EDGE OF THE #7 ELECTRODE CRIMP SLEEVE.¿ ANALYSIS OF LEAD TWO FOUND ¿THE SETSCREW IMPRESSION ON THE #0 CONNECTOR INDICATED THAT THE LEAD WAS NOT COMPLETELY INSERTED INTO THE INS CONNECTOR PORT. THERE WERE ALSO BALSEAL CONNECTOR SPRING IMPRESSIONS IN THE TUBING BETWEEN THE CONNECTORS.¿ ANALYSIS OF BOTH ANCHORS FOUND ¿NO ANOMALY.¿

    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 THE PATIENT EXPERIENCED A ¿SUSPECTED LEAD MIGRATION¿ AND ¿DISLODGEMENT.¿ X-RAY ANALYSIS ¿CONFIRMED ONE LEAD WAS COILED¿ INSIDE OF THE PREVIOUS DEVICE POCKET SITE ON THE PATIENT¿S BACK. THE X-RAY RESULTS ALSO INDICATED THE ¿OTHER LEAD APPEARED TO BE MORE LATERAL THAN AT THE INITIAL IMPLANT,¿ HOWEVER INITIAL X-RAY RESULTS WERE NOT AVAILABLE. WHEN THE SURGEON OPENED THE PREVIOUS DEVICE POCKET, IT WAS ¿POINTED OUT THAT BOTH ANCHORS WERE SITTING LATERALLY ACROSS THE SPINE, NOT VERTICALLY NEXT TO THE SPINE AS WHEN IMPLANTED.¿ IT WAS NOTED THAT WHILE REMOVING THE LEADS, THE SURGEON ¿COMMENTED THAT IT APPEARED THE SUTURES HAD BECOME LOOSE AROUND THE ANCHORS¿ AND THAT ¿BOTH ANCHORS APPEARED TO STILL BE FIRMLY CONNECTED TO THE LEAD BODY.¿ THE SURGEON REPLACED BOTH LEADS AT THE TIME OF THE PROCEDURE AND HAD CUT THE LEADS AS PART OF THE REMOVAL PROCESS. THE PATIENT WAS REPORTEDLY OBSERVED TO HAVE RECEIVED ¿ GOOD STIMULATION AND COVERAGE OF THE PAIN AREA¿ DURING INTRAOPERATIVE TESTING. ADDITIONAL INFORMATION WAS REQUESTED REGARDING THE PATIENT¿S OUTCOME FOLLOWING THE CONCLUSION OF THE REPLACEMENT PROCEDURE. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600335 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention