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 NIPG2000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Wound Dehiscence (1154)
Event Date 04/27/2021
Event Type  Injury  
Manufacturer Narrative
The manufacturing records were reviewed and no issues were found.The device was not available for return.
 
Event Description
It was reported to nevro that the patient developed wound dehiscence at the ipg pocket site.The device was removed and there have been no reports of further complications regarding this event.It was noted that the patient received effective pain relief from the device prior to the device removal.
 
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 Key11904323
MDR Text Key253470737
Report Number3008514029-2021-00201
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00813426020510
UDI-Public00813426020510
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 05/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/03/2021
Device Model NumberNIPG2000
Device Catalogue NumberNIPG2000
Device Lot Number9444079
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/03/2019
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) Other;
Patient Age38 YR
-
-