BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 10409508 · Received August 14, 2020

    Report

    Report Number
    2182207-2020-00711
    Event Type
    Injury
    Date Received
    August 14, 2020
    Date of Event
    August 22, 2019
    Report Date
    August 14, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: PLEASE NOTE THAT THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    HUANG, J., YANG, S., YANG, J., SUN, W., JIANG, C., ZHOU, J., LI, D., XIONG, D., BATES, D., XIAO, L. EARLY TREATMENT WITH TEMPORARY SPINAL CORD STIMULATION EFFECTIVELY PREVENTS DEVELOPMENT OF POSTHERPETIC NEURALGIA. PAIN PHYSICIAN. 2020. 23(2):E219-E230. SUMMARY: SOME 7.7% OF THE CHINESE POPULATION SUFFER FROM HERPES ZOSTER EACH YEAR, WITH 29.8% PROCEEDING ON TO DEVELOP POSTHERPETIC NEURALGIA (PHN). THIS AMOUNTS TO OVER 32 MILLION PEOPLE PER YEAR. PHN IS PRECEDED BY 2 PHASES OF PAIN: ACUTE HERPETIC NEURALGIA (AHN), AND SUBACUTE HERPETIC NEURALGIA (SHN). CONSIDERING THE LARGE INDIVIDUAL AND ECONOMIC BURDEN, PREVENTING THE TRANSITION OF AHN/SHN TO PHN IS CRUCIAL. HOWEVER, TO DATE THIS HAS BEEN DIFFICULT. TO EVALUATE THE EFFICACY OF TEMPORARY SPINAL CORD STIMULATION (TSCS) TREATMENT AND PREVENTION OF PHN. A RETROSPECTIVE, OBSERVATIONAL STUDY. DEPARTMENT OF PAIN MEDICINE. FROM 2013 TO 2017, 99 PATIENTS WITH AHN (N = 42), SHN (N = 34), AND PHN (N = 23) UNDERWENT TSCS TREATMENT (7-14 DAYS) AFTER FAILED PHARMACOLOGIC AND INTERVENTIONAL THERAPIES. VISUAL ANALOG SCALE (VAS), PITTSBURGH SLEEP QUALITY INDEX (PSQI), AND ANALGESIC CONSUMPTION WERE RECORDED AT BASELINE, POST-TSCS, AND 1, 3, 6, AND 12 MONTHS AFTER TSCS TREATMENT. POOLED RESULTS DEMONSTRATED STATISTICALLY SIGNIFICANT DECREASES IN VAS SCORES AND PSQI POST-TSCS AND AT 1, 3, 6, AND 12 MONTHS FOLLOW-UP (P < 0.001). WHEN COMPARED WITH THE PHN GROUP, BOTH AHN AND SHN GROUPS WERE CLINICALLY AND STATISTICALLY IMPROVED IN VAS SCORES AND PSQI (P < 0.001). ANALGESIC CONSUMPTION DECREASED IN ALL 3 GROUPS AFTER TSCS TREATMENT, AND DOWNWARD LINEAR GRADIENT OF MEDICATION IN THE AHN GROUP WAS MORE SIGNIFICANT THAN THAT IN THE SHN AND PHN GROUPS. AT 12 MONTHS FOLLOW-UP, 2.5% (1/40) PATIENTS IN THE AHN GROUP, 16.0% (4/25) IN THE SHN GROUP, AND 62.5% (10/16) IN THE PHN GROUP HAD ONGOING PAIN = 3/10 VAS SCORE REQUIRING ANALGESIA. EXPRESSED DIFFERENTLY, AT 12 MONTHS, 97.5% OF THE AHN GROUP AND 84% OF THE SHN GROUP HAD PAIN OF 2/10 VAS SCORE OR LESS VERSUS ONLY 37.5% OF THE PHN GROUP. THIS WAS A SINGLE-CENTER, RETROSPECTIVE STUDY, WHICH MADE IT DIFFICULT TO COLLECT COMPLETE DATA FOR ALL VARIABLES. THE THERAPEUTIC EFFECT OF TSCS COULD NOT BE STUDIED INDEPENDENTLY. THIS RETROSPECTIVE ANALYSES OF 99 PATIENTS TREATED WITH TSCS (7-14 DAYS) SUGGESTS THAT TSCS MAY BE EFFECTIVE FOR TREATING AND PREVENTING PHN. EARLY TREATMENT WITHIN 4 TO 8 WEEKS WAS MORE LIKELY TO RESULT IN PAIN = 2/10 VAS SCORE, IMPROVEMENT IN SLEEP, AND NO REQUIREMENT FOR ANALGESIA AT 12 MONTHS. EARLY TSCS MAY BE A PROMISING PREVENTION STRATEGY AGAINST THE DEVELOPMENT OF CHRONIC NEUROPATHIC PAIN FOLLOWING HERPES ZOSTER INFECTION. FURTHER RESEARCH IS JUSTIFIED. REPORTED EVENTS: 9 PATIENTS WHO HAVE POPULATION SUFFER FROM HERPES ZOSTER EXPERIENCED A LEAD MIGRATION. 6 PATIENTS WHO HAVE POPULATION SUFFER FROM HERPES ZOSTER EXPERIENCED A LOCAL INFECTION OF THE PUNCTURE SITE. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875748 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other