BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    MDR report key: 6637365 · Received June 13, 2017

    Report

    Report Number
    3007566237-2017-02350
    Event Type
    Malfunction
    Date Received
    June 13, 2017
    Date of Event
    February 11, 2017
    Report Date
    June 13, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION; INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM INVOLVED IN THE REPORTED EVENT; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    KIM, JH., SHIN, SH., LEE, YR., LEE, HS., CHON, JY., SUNG, CH., HONG, SJ., LEE, JY., MOON, HS. ULTRASOUND-GUIDED PERIPHERAL NERVE STIMULATION FOR NEUROPATHIC PAIN AFTER BRACHIAL PLEXUS INJURY: TWO CASE REPORTS. J ANESTH. 2017. DOI: 10.1007/S00540-017-2315-5. SUMMARY: BRACHIAL PLEXUS INJURY (BPI) OFTEN CAUSES SEVERE NEUROPATHIC PAIN THAT BECOMES CHRONIC AND DIFFICULT TO TREAT PHARMACOLOGICALLY OR SURGICALLY. HERE, WE DESCRIBE TWO CASES OF SUCCESSFUL TREATMENT OF BPI WITH PERIPHERAL NERVE STIMULATION (PNS). BOTH PATIENTS HAD EXPERIENCED SEVERE NEUROPATHIC PAIN AFTER INCOMPLETE BPI FOR A LONG TIME (32 AND 17 YEARS) AND DID NOT RESPONSE TO MEDICATION, RADIOFREQUENCY NEUROABLATION, OR SPINAL CORD STIMULATION. AFTER PNS USING ULTRASOUND, THEIR PAIN WAS RELIEVED BY MORE THAN 50% OVER THE COURSE OF 1 YEAR. BOTH PATIENTS WERE SATISFIED WITH THEIR IMPROVED SLEEP AND QUALITY OF LIFE. WE CONCLUDE THAT PNS COULD BE AN ALTERNATIVE THERAPEUTIC MODALITY FOR NEUROPATHIC PAIN AFTER BPI AS IT PROVIDES DIRECT NERVE STIMULATION, HAS FEW COMPLICATIONS, AND IS EASY TO PERFORM. REPORTED EVENTS: 1. A (B)(6)-YEAR-OLD MAN WITH PERIPHERAL NERVE STIMULATION (PNS) OF THE RADIAL NERVE FOR PAIN RELATED TO THEIR BRACHIAL PLEXUS INJURY (BPI) ACHIEVED PAIN RELIEF, BUT THERE WAS A ¿CHANGE IN THE ELECTRICAL SIGNAL¿ AT 1 MONTH POST-IMPLANT BECAUSE OF LEAD MIGRATION. THIS WAS CORRECTED BY REPROGRAMMING AND THE PATIENT MAINTAINED A =50% REDUCTION IN NRS PAIN SCORE, AS WELL AS A DECREASE IN MEDICATION REQUIREMENTS, AND IMPROVED SLEEP AND QUALITY OF LIFE. IT WAS NOTED THAT THE PATIENT WAS IMPLANTED WITH AN 8-ELECTRODE PERCUTANEOUS LEAD, BUT IT WAS NOT POSSIBLE TO ASCERTAIN ANY FURTHER SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416744 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR