BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 14880178 · Received June 30, 2022

    Report

    Report Number
    2182207-2022-01224
    Event Type
    Injury
    Date Received
    June 30, 2022
    Report Date
    June 30, 2022
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: CUCURUZ B, KOPP R, HAMPE-HECHT H, ET AL. TREATMENT OF END-STAGE PERIPHERAL ARTERY DISEASE BY NEUROMODULATION. CLIN HEMORHEOL MICROCIRC. 2022.10.3233/CH-221436. LITERATURE SUMMARY: NEUROMODULATION IS A THERAPEUTIC OPTION TO IMPROVE LIMB SALVAGE IN END-STAGE PERIPHERAL ARTERIAL DISEASE (PAD), BUT THERE IS NO CONSENSUS ON INDICATION FOR SPINAL CORD STIMULATION (SCS) IN PAD PATIENTS. THE AIM OF THIS STUDY WAS TO PRESENT END-STAGE PAD PATIENT OUTCOMES TREATED WITH SCS. THE AUTHORS CONCLUDED THAT SCS IMPLANTATION IN PATIENTS WITH END-STAGE PAD CAN ENABLE LIMB SALVAGE IN A HIGH PERCENTAGE OF CASES AND INCREASE MOBILITY DUE TO PAIN REDUCTION. THE ROLE OF MICROCIRCULATION IN THESE IMPROVEMENTS NEEDS TO BE INVESTIGATED IN FURTHER STUDIES. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE SEX OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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. DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION THE DEVICE WAS USED FOR WAS FOR THE TREATMENT OF END-STAGE PERIPHERAL ARTERY DISEASE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 97702; PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 97702. 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

    REPORTED EVENTS: 1 PATIENT DEVELOPED GENERATOR INFECTION AFTER ONE MONTH. 2 PATIENTS¿ GLUTEAL IMPLANTABLE NEUROSTIMULATOR (INS) PLACEMENT CAUSED IMPINGEMENT PAIN OF THE SCIATIC NERVE, REQUIRING DEVICE REMOVAL. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1609783 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC NEUROMODULATION 97702 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention