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 LEAD3005-70B
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Hematoma (1884); Numbness (2415)
Date of Event 08/20/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The leads were explanted but discarded.The manufacturing records were reviewed and no non-conformities were found.
 
Event or Problem Description
It was reported to nevro that shortly after the implant procedure, the patient experienced no feelings in the legs.The patient was admitted to the hospital and subsequently the leads were removed.The physician thinks there was an epidural hematoma.The patient has recovered all feelings in the legs and is recovering.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SENZA
Common Device Name
NEVRO SENZA
Manufacturer (Section D)
NEVRO CORP.
1800 bridge parkway
redwood city CA 94065
MDR Report Key7879489
Report Number3008514029-2018-00392
Device Sequence Number11281781
Product Code LGW
UDI-Device Identifier00813426020404
UDI-Public00813426020404
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P130022
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/14/2018
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
Operator of Device Health Professional
Device Expiration Date07/06/2020
Device Model NumberLEAD3005-70B
Device Lot Number94405762
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/20/2018
Initial Report FDA Received Date09/14/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age74 YR
-
-