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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEVRO CORP. SENZA; NEVRO SENZA

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NEVRO CORP. SENZA; NEVRO SENZA Back to Search Results
Model Number LEAD1058-50B
Device Problems Fracture (1260); High impedance (1291)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/06/2022
Event Type  Injury  
Manufacturer Narrative
The manufacturing 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.The device was not returned.
 
Event Description
It was reported that the patient underwent revision surgery for high impedance.During the revision surgery, it was noted that the lead was fractured at the anchor site proximal to the patient and could not be retrieved by the physician.All implants, with the exception of the fractured lead, were removed.The patient was then closed and the patient was referred to neurosurgery for the placement of a paddle lead and the removal of the fractured lead.
 
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Brand Name
SENZA
Type of Device
NEVRO SENZA
Manufacturer (Section D)
NEVRO CORP.
1800 bridge parkway
redwood city CA 94065
Manufacturer Contact
catherine aronson
1800 bridge parkway
redwood city, CA 94065
6504333218
MDR Report Key14897559
MDR Text Key295230948
Report Number3008514029-2022-00323
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00813426020022
UDI-Public00813426020022
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P130022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 07/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/21/2022
Device Model NumberLEAD1058-50B
Device Catalogue NumberLEAD1058-50B
Device Lot Number94442878
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/06/2022
Initial Date FDA Received07/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Other;
Patient SexMale
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