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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 Patient Problem/Medical Problem (2688)
Event Date 11/06/2017
Event Type  Injury  
Manufacturer Narrative
The device was not explanted. The manufacturing records were reviewed and no nonconformities were found.
 
Event Description
It was reported to nevro that two days after activation of therapy, a patient with type-1 diabetes and complex regional pain syndrome experienced fluctuations in blood glucose levels. The patient became hypoglycemic four to five times a day. Therapy was turned off and the fluctuations in blood glucose levels subsided. Subsequently, therapy was turned on, and the fluctuations in blood glucose levels returned. The physician and diabetologist decided to adjust the patient's insulin units for the blood glucose, which mitigated the fluctuations. Follow-up report indicated that the physician does not believe that the fluctuations in blood sugar were device related. The patient is receiving good pain relief and there were no reports of further complications.
 
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Brand NameSENZA
Type of DeviceNEVRO 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 Key7116209
MDR Text Key94788665
Report Number3008514029-2017-00360
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
Type of Report Initial
Report Date 12/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/12/2019
Device Model NumberNIPG1500
Device Catalogue NumberNIPG1500
Device Lot Number9439813
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/15/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/12/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/13/2017 Patient Sequence Number: 1
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