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 LEAD1058-70B
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Erosion (2075)
Event Date 05/31/2020
Event Type  Injury  
Manufacturer Narrative
The manufacturing records were reviewed and no issues were found related to the nature of the complaint.The device was not returned.
 
Event Description
It was reported to nevro that the patient experienced skin erosion at the lead site.The patient was given antibiotics prophylactically and the physician removed the device.The physician plans to re-implant once the incision has healed.There have been no reports of further complications regarding this event.
 
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 Key10191762
MDR Text Key196313675
Report Number3008514029-2020-00614
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00813426020046
UDI-Public00813426020046
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 06/24/2020
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 Date06/23/2021
Device Model NumberLEAD1058-70B
Device Catalogue NumberLEAD1058-70B
Device Lot Number94430874
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/01/2020
Initial Date FDA Received06/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/23/2018
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 Age48 YR
-
-