BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 18665251 · Received February 7, 2024

    Report

    Report Number
    2182207-2024-00525
    Event Type
    Injury
    Date Received
    February 7, 2024
    Date of Event
    February 1, 2018
    Report Date
    February 7, 2024
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: BUCMA T, SAVIC O, BOSKIC T, ARAMBASIC TOPIC L, SLADOJEVIC I, NOVAKOVIC BURSAC S. SPINAL CORD STIMULATION IN CHRONIC PAIN TREATMENT - FIRST EXPERIENCES IN BOSNIA AND HERZEGOVINA. MED GLAS (ZENICA). 2023;20(1)DOI:10.17392/1507-22 LITERATURE ABSTRACT: THE AUTHORS AIMED TO DESCRIBE RESULTS OF SPINAL CORD STIMULATION TECHNIQUE WHEN THE CONVENTIONAL MULTIDISCIPLINARY TREATMENT OF NEUROPATHIC OR MIXED PAIN FAILED. THE AUTHORS ULTIMATELY CONCLUDED THAT SHORT-TERM AND LONG-TERM FOLLOW UP SHOWED A LONG LASTING PAIN REDUCTION AND IMPROVEMENT OF FUNCTIONALITY IN ALL PATIENTS. B3: PLEASE NOTE THAT ONLY THE YEAR OF THE EVENT DATE IS KNOWN AT THIS TIME. B5: IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENTS 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. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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 · 0

    IT WAS REPORTED THAT A 74 YEAR OLD FEMALE PATIENT WITH A HISTORY OF ¿LUMBAR AREA PAIN SPREADING DOWN THE RIGHT LEG SINCE 2008¿ UNDERWENT A PERCUTANEOUS LEAD IMPLANT IN (B)(6) 2018. THE PATIENT HAD HER SYSTEM REMOVED AFTER SIX MONTHS DUE TO ¿DIFFICULTY TOLERATING THE PARESTHESIA, DESPITE NUMEROUS ATTEMPTS TO SET NEW PROGRAM PARAMETERS.¿ IT WAS STATED THE REASON FOR EXPLANT WAS THE ¿PARESTHESIA IN THE PAIN REGION¿ THAT THE PATIENT ¿COULD NOT BEAR REGARDLESS OF NUMEROUS ATTEMPTS TO SET NEW PROGRAM PARAMETERS.¿ THE AUTHORS NOTED THAT ¿THIS COULD BE CAUSED BY INTOLERANCE TO THE SYSTEM, WHICH WAS IMPOSSIBLE TO CONFIRM PREOPERATIVELY.¿ NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2278463 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC NEUROMODULATION 97714 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention