BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3829561 · Received May 23, 2014

    Report

    Report Number
    3007566237-2014-01422
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 28, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    VALLE-GILER, E.P., SULAIMAN, W.A. MIDLINE MINIMALLY INVASIVE PLACEMENT OF SPINAL CORD STIMULATORS: A TECHNICAL NOTE. THE OCHSNER JOURNAL. 2014;14(1):51-56. SUMMARY: SPINAL CORD STIMULATORS (SCSS) HAVE CONVENTIONALLY BEEN IMPLANTED THROUGH OPEN APPROACHES REQUIRING EXTENSIVE MUSCLE DISSECTION TO PERFORM LAMINECTOMIES AND PERMANENTLY PLACE THE PADDLE LEAD. THIS APPROACH COULD CONTRIBUTE TO WORSENING THE PAIN SYNDROME IN PATIENTS WHO EXPERIENCE CHRONIC PAIN. IN AN ATTEMPT TO REDUCE OPERATIVE TIMES, MINIMIZE BLOOD LOSS AND POSTOPERATIVE PAIN, AND EASE THE TECHNICAL CHALLENGES OF PLACING THE PADDLE LEAD IN THE MIDLINE VIA A PARAMEDIAN AND OFF-MIDLINE INCISION, WE DESIGNED A NEW MINIMALLY INVASIVE SURGERY (MIS) TECHNIQUE TO PLACE THE PADDLE LEAD USING A TUBULAR RETRACTOR SYSTEM THROUGH A TRUE MIDLINE APPROACH. WE PERFORMED A RETROSPECTIVE REVIEW OF ALL MIS PADDLE LEAD PLACEMENTS PERFORMED BY THE SENIOR AUTHOR BETWEEN OCTOBER 2010 AND JUNE 2013. PATIENT DEMOGRAPHICS; CLINICAL INDICATIONS FOR PLACEMENT OF PADDLE LEAD; LOCATION OF PADDLE LEAD; AND PERIOPERATIVE DATA INCLUDING BLOOD LOSS, LENGTH OF SURGERY, AND SURGICAL AND PERIOPERATIVE MORBIDITY WERE RECORDED. BETWEEN OCTOBER 2010 AND JUNE 2013, 78 PATIENTS HAD MIS PLACEMENT OF PADDLE LEAD SCSS. PATIENT AGES RANGED FROM 27 TO 87 YEARS OLD, WITH A MEAN AGE OF 59. THE MOST COMMON LEVELS FOR PADDLE LEAD PLACEMENT WERE T8 AND T9. NO MINOR OR MAJOR NEUROLOGIC COMPLICATIONS OCCURRED IN OUR PATIENT POPULATION. NO PATIENT WAS READMITTED AFTER BEING DISCHARGED FROM THE HOSPITAL AND ALL SURGERIES WERE OUTPATIENT PROCEDURES. WE HAD A MIGRATION RATE COMPARABLE TO OPEN TECHNIQUES AND MINIMAL BLOOD LOSS. OUR TECHNIQUE IS SAFE AND EFFECTIVE AND CARRIES MINIMAL SURGICAL MORBIDITY COMPARED TO STANDARD OPEN TECHNIQUES FOR PLACEMENT OF SCSS. REPORTED EVENTS: 11 PATIENTS HAD TO UNDERGO A REVISION SURGERY DUE TO PADDLE LEAD MIGRATION. IT WAS NOTED THAT THE REVISION SURGERY WAS PERFORMED WITH AN OPEN APPROACH A MEAN TIME OF 53.8 DAYS AFTER THE INITIAL IMPLANT. THE REPORTER STATED THAT ALL OF THE MIGRATIONS WERE A RESULT OF DORSAL MIGRATION OF THE PADDLE LEADS LIKELY RELATED TO POOR ANCHORING AND EARLY EXCESSIVE MOBILIZATION OF THE PATIENTS, ESPECIALLY FLEXION MOVEMENT. THREE PATIENTS HAD TO UNDERGO A REVISION SURGERY DUE TO PADDLE LEAD MIGRATION. THE REPORTER STATED THAT THE PATIENT REPORTED FALLS WITH IMMEDIATE SCS MALFUNCTION AFTER THE FALL. IT WAS NOTED THAT THE REVISION SURGERY WAS PERFORMED WITH AN OPEN APPROACH A MEAN TIME OF 53.8 DAYS AFTER THE INITIAL IMPLANT. THE REPORTER STATED THAT ALL OF THE MIGRATIONS WERE A RESULT OF DORSAL MIGRATION OF THE PADDLE LEADS LIKELY RELATED TO POOR ANCHORING AND EARLY EXCESSIVE MOBILIZATION OF THE PATIENTS (ESPECIALLY FLEXION MOVEMENT) AND/OR PATIENT FALLS. ONE PATIENT UNDERWENT REMOVAL AND REPLACEMENT OF SPINAL CORD ELECTRODES DUE TO MALPOSITION. ONE PATIENT HAD TO UNDERGO REMOVAL OF THE ENTIRE SPINAL CORD STIMULATION (SCS) SYSTEM BECAUSE OF AN INFECTION. THE REPORTER STATED THAT THE INFECTION STARTED OVER THE BATTERY SITE AND SPREAD UP TO THE PADDLE LEAD INCISION SITE. THE SOURCE LITERATURE DID NOT INCLUDE ANY SPECIFIC DEVICE INFORMATION. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307582 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention