Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEVRO CORP. SENZA; NEVRO SENZA
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NEVRO CORP. SENZA; NEVRO SENZA Back to Search Results
Model Number LEAD1058-50B
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Pain (1994)
Event Date 10/19/2021
Event Type  Injury  
Event Description
It was reported to nevro that the patient experienced pain at the lead site and developed an infection.The physician performed a wound washout.The patient was treated with antibiotics and recovered without sequelae.
 
Manufacturer Narrative
The manufacturing and sterilization records were reviewed, and no relevant nonconformities were found.The device was not removed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12815760
MDR Text Key280809013
Report Number3008514029-2021-00519
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 Non-Healthcare Professional
Type of Report Initial
Report Date 11/15/2021
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? No
Device Operator Health Professional
Device Expiration Date03/31/2024
Device Model NumberLEAD1058-50B
Device Catalogue NumberLEAD1058-50B
Device Lot Number94498015
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/19/2021
Initial Date FDA Received11/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/27/2021
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) Other;
Patient SexFemale
-
-