BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3102874 · Received May 9, 2013

    Report

    Report Number
    3007566237-2013-01568
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 11, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AMRANI, J. EPIDURAL HEMATOMA FOLLOWING IMPLANTATION OF A PERMANENT SPINAL CORD STIMULATOR PADDLE. NEUROMODULATION. 2013. DOI: 10.111 1/NER.12059. SUMMARY: NEUROLOGIC INJURY IS THE MOST FEARED COMPLICATION OF SPINAL CORD STIMULATOR IMPLANTATION. UNFORTUNATELY, THIS TOPIC HAS RECEIVED LITTLE ATTENTION IN THE LITERATURE, MAKING IT DIFFICULT TO ASSESS THE CAUSES AND POSSIBLE STRATEGIES TO AVOID THESE INJURIES. THIS IS A REPORT OF A CASE OF INCOMPLETE SPINAL CORD INJURY AND EPIDURAL HEMATOMA THAT DEVELOPED IN A PATIENT 36 HOURS AFTER IMPLANTATION. IT IS HOPED THAT THE LESSONS LEARNED IN THIS CASE WILL HELP OTHERS AVOID OR PROMPTLY RECOGNIZE AND TREAT THIS DREADED COMPLICATION. REPORTED EVENT: IT WAS REPORTED THAT TWO DAYS AFTER THE IMPLANTATION PROCEDURE, THE PATIENT WALKED INTO HIS LOCAL EMERGENCY DEPARTMENT COMPLAINING OF INCREASED BACK PAIN, WEAKNESS OF LEFT LOWER EXTREMITY AND URINARY RETENTION. A PHYSICAL EXAM REVEALED "A VERY SMALL AMOUNT OF BLOOD" ON THE THORACIC DRESSING WITH NO SIGNIFICANT SWELLING OR ERYTHEMA AROUND THE INCISION. PINPRICK SENSIBILITY WAS DECREASED IN THE REMAINDER OF THE LOWER EXTREMITIES. THE PATIENT HAD AN EPISODE OF URINARY INCONTINENCE DURING THE EXAM AND A FOLEY CATHETER WAS PLACED. AN X-RAY SHOWED NO CHANGE IN POSITION OF THE LEAD COMPARED WITH THE X-RAY OBTAINED INTRAOPERATIVELY. DUE TO THE SUDDENNESS OF THE ONSET OF THE NEUROLOGICAL DEFICIT, THE PATIENT WAS RETURNED TO THE OPERATING ROOM "IMMEDIATELY" FOR REMOVAL OF THE IMPLANT AND EXPLORATION OF THE THORACIC WOUND TO RULE OUT AN EPIDURAL HEMATOMA. AT SURGERY, THE PATIENT WAS FOUND TO HAVE A "MODERATE" SUBFASCIAL HEMATOMA EXTENDED INTO THE EPIDURAL SPACE. THE STIMULATOR AND IMPLANTED NEUROSTIMULATOR WERE REMOVED, AND THE HEMATOMA WAS EVACUATED. THE MOTOR STRENGTH IN THE PATIENT'S LEFT LOWER EXTREMITY IMPROVED A FULL GRADE EACH DAY. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2012, FULLY AMBULATORY WITH NO NUMBNESS OR SADDLE ANESTHESIA. THE PATIENT CONTINUED TO HAVE URINARY RETENTION, WHICH RESOLVED OVER THE NEXT SIX WEEKS. THE PATIENT MADE A FULL RECOVERY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. SEE ATTACHED LITERATURE ARTICLE.

    Description of Event or Problem · 1

    IT WAS STATED THAT DEEP TENDON REFLEXES WERE DEPRESSED SYMMETRICALLY IN THE LOWER EXTREMITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203355 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention