BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5197319 · Received November 3, 2015

    Report

    Report Number
    3007566237-2015-03180
    Event Type
    Injury
    Date Received
    November 3, 2015
    Date of Event
    August 10, 2015
    Report Date
    October 13, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT P ROVIDED IN THE PUBLISHED LITERATURE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ELDABE, S., THOMSON, S., DUARTE, R., BROOKES, M., DEBELDER, M., RAPHAEL, J., DAVIES, E., TAYLOR, R. THE EFFECTIVENESS AND COST-EFFECTIVENESS OF SPINAL CORD STIMULATION FOR REFRACTORY ANGINA (RASCAL STUDY): A PILOT RANDOMIZED CONTROLLED TRIAL. NEUROMODULATION. 2015. DOI: 10.1111/NER.12349. SUMMARY: PATIENTS WITH "REFRACTORY ANGINA" (RA) UNSUITABLE FOR CORONARY REVASCULARIZATION EXPERIENCE HIGH LEVELS OF HOSPITALIZATION AND POOR HEALTH-RELATED QUALITY OF LIFE. RANDOMIZED TRIALS HAVE SHOWN SPINAL CORD STIMULATION (SCS) TO BE A PROMISING TREATMENT FOR CHRONIC STABLE ANGINA AND RA; HOWEVER, NONE HAS COMPARED SCS WITH USUAL CARE (UC). THE AIM OF THIS PILOT STUDY WAS TO ADDRESS THE KEY UNCERTAINTIES OF CONDUCTING A DEFINITIVE MULTICENTER TRIAL TO ASSESS THE CLINICAL AND COST-EFFECTIVENESS OF SCS IN RA PATIENTS, I.E., RECRUITMENT AND RETENTION OF PATIENTS, BURDEN OF OUTCOME MEASURES, OUR ABILITY TO STANDARDIZE UC IN A UK NHS SETTING. REPORTED EVENTS: 1. ONE PATIENT WITH SPINAL CORD STIMULATION (SCS) FOR REFRACTORY ANGINA EXPERIENCED A SUPERFICIAL INFECTION RELATED TO SCS THERAPY. THE PATIENT REQUIRED HOSPITALIZATION FOR INTRAVENOUS ANTIBIOTIC TREATMENT OF THE INFECTION. 2. ONE PATIENT WITH SPINAL CORD STIMULATION (SCS) FOR REFRACTORY ANGINA EXPERIENCED A SUPERFICIAL INFECTION RELATED TO SCS THERAPY. 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. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728551 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 00065 YR Required Intervention