BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENZA

    MDR report key: 19512767 · Received June 11, 2024

    Report

    Report Number
    3008514029-2024-00520
    Event Type
    Injury
    Date Received
    June 11, 2024
    Date of Event
    August 6, 2023
    Report Date
    October 8, 2024
    Manufacturer
    NEVRO CORP.
    Product Code
    LGW
    UDI-DI
    00813426020602
    PMA / PMN Number
    P130022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING AND STERILIZATION RECORDS WERE REVIEWED AND NO RELEVANT NONCONFORMITIES WERE FOUND. 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.

    Additional Manufacturer Narrative · 0

    CORRECTED SECTIONS: H2, THE CODES IN H6 REMAIN UNCHANGED FROM THE PREVIOUS SUBMITTED FORM. THIS MW # (B)(4) IS BEING SUBMITTED AS A CORRECTION FOR MW # (B)(4) WHICH WAS SUBMITTED IN ERROR AND IS A DUPLICATE OF MW # (B)(4), SUBMITTED ON 25AUG2023. NO NEW INFORMATION IS PROVIDED. PLEASE REFER TO MW# (B)(4) FOR THE COMPLETE AND CORRECT REPORT, MW # (B)(4) CONTAINS THE VALID INFORMATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION AT THE POCKET SITE. THE PATIENT HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814975 SENZA NEVRO SENZA LGW NEVRO CORP. NIPG2500 9453159 00813426020602

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R