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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 NIPG1500
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Abscess (1690)
Event Date 11/21/2017
Event Type  Injury  
Manufacturer Narrative
The device was explanted, but was not returned for analysis.The manufacturing records were reviewed and no nonconformities were found.
 
Event Description
During a routine follow-up, it was reported to nevro that a patient presented to the emergency room after experiencing swelling at the ipg site.The device was explanted after an abscess was confirmed by an x-ray.There were no reports of further complications.
 
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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
rey nossa
1800 bridge parkway
redwood city, CA 94065
6504332742
MDR Report Key7127211
MDR Text Key95172098
Report Number3008514029-2017-00362
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00813426020015
UDI-Public00813426020015
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 Other
Type of Report Initial
Report Date 12/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date05/30/2019
Device Model NumberNIPG1500
Device Catalogue NumberNIPG1500
Device Lot Number9440268
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/30/2017
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 Age70 YR
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