BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENZA

    MDR report key: 16755693 · Received April 17, 2023

    Report

    Report Number
    3008514029-2023-00211
    Event Type
    Malfunction
    Date Received
    April 17, 2023
    Date of Event
    January 17, 2023
    Report Date
    April 17, 2023
    Manufacturer
    NEVRO CORP.
    Product Code
    LGW
    PMA / PMN Number
    P130022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOR A1, D4, AND H4: NO INFORMATION WAS PROVIDED ON DEVICE INCIDENT REPORT (DIR) (B)(4). THIS PEV IS LIKELY RELATED TO PEV-127615. HOWEVER, DUE TO A LACK OF ANY PATIENT OR PRODUCT IDENTIFIER IN THE REPORT, WE ARE UNABLE TO CONFIRM THIS. NEVRO SUBMITS THIS REPORT IN COMPLIANCE WITH FDA¿S MEDICAL DEVICE REPORTING REGULATIONS UNDER 21 CFR PART 803. NEVRO HAS COMPLIED WITH REGULATORY INVESTIGATION REQUIREMENTS AND IS SUBMITTING ALL INFORMATION THAT IS REASONABLY KNOWN TO US AT THIS TIME. HOWEVER, WE MAY NOT HAVE BEEN ABLE TO CONFIRM THIS INFORMATION OR COMPLETE THE INVESTIGATION WITHIN THE TIMEFRAME FOR FILING THIS REPORT. WE MAY HAVE GIVEN NO RESPONSE OR AN INCOMPLETE RESPONSE TO CERTAIN QUESTIONS BECAUSE WE DO NOT CURRENTLY HAVE INFORMATION AVAILABLE TO PROVIDE A COMPLETE RESPONSE. IF WE LATER OBTAIN ANY REQUIRED INFORMATION THAT WAS NOT AVAILABLE AT THE TIME OF THIS INITIAL REPORT, WE WILL SUBMIT A SUPPLEMENTAL REPORT. THIS REPORT IS NOT AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT WAS DEFECTIVE, THAT IT MALFUNCTIONED, OR THAT IT CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. WE MAY CONCLUDE THAT THE DEVICE HAD NO DEFECT, DID NOT MALFUNCTION, OR DID NOT CAUSE OR CONTRIBUTE TO A REPORTABLE EVENT. SOME OF THE ITEMS ON THIS FORM INCLUDE FORCED-CHOICE TERMS USED BY THE FDA FOR REPORTING PURPOSES THAT DO NOT NECESSARILY REFLECT NEVRO¿S CONCLUSIONS ABOUT THE CAUSES OR NATURE OF THE EVENT. THIS STATEMENT SHOULD BE INCLUDED WITH ANY FREEDOM OF INFORMATION ACT RESPONSE. H3 OTHER TEXT : THE DEVICE WAS NOT REMOVED.

    Description of Event or Problem · 0

    DEVICE INCIDENT REPORT (DIR) (B)(4), WAS RECEIVED BY THE THERAPEUTIC GOODS ADMINISTRATION (TGA) FROM A HEALTHCARE PROFESSIONAL/USER, WITH THE FOLLOWING DETAILS. CLINICAL EVENT INFORMATION: IMPLANT OF SPINAL CORD STIMULATOR FOR PAIN MANAGEMENT IN THE C-SPINE REGION ON (B)(6) 2018. LATERAL LEAD MIGRATION OF LEFT SIDE LEAD BY MARCH 2019, SO HAD TO PERFORM A REVISION SURGERY TO RE-ALIGN IT TO MID-LINE IN THE C-SPINE REGION. LEAD BREAKAGE AND MIGRATION UP TO THE C1 OF THE LEFT-SIDE LEAD AGAIN ON (B)(6) 2023. NEUROSURGEON NOW INVOLVED IN CARE AND PROGNOSIS IS THAT THERE IS PROBABLY NO IMMEDIATE DANGER BUT WILL NEED A LAMINECTOMY IN THE COMING MONTHS TO SECURE THE LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2319193 SENZA NEVRO SENZA LGW NEVRO CORP. NO INFORMATION NO INFORMATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown