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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 NIPG2500
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Burn(s) (1757); Hypersensitivity/Allergic reaction (1907)
Event Date 03/09/2021
Event Type  Injury  
Manufacturer Narrative
The manufacturing records were reviewed and no relevant nonconformities were found. A review of the available diagnostic data shows that the temperature of the device was within the expected range. The device was not returned.
 
Event Description
It was reported to nevro that the patient experienced superficial burn marks at the pocket site. The patient was given antibiotics and wound treatment. The wound healed without sequelae and the patient remains under medical supervision. The patient continues to use the device to find effective pain relief.
 
Manufacturer Narrative
This report is to update and additional information received by nevro.
 
Event Description
Follow-up indicated that the physician believed the patient to be allergic to the charging paddle (part of the senza system). The physician instructed the patient to no longer charge directly on the skin. There have been no further reports of burn marks following the physician's instructions.
 
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Brand NameSENZA
Type of DeviceNEVRO 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 Key11615923
MDR Text Key243833375
Report Number3008514029-2021-00128
Device Sequence Number1
Product Code LGW
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,Followup
Report Date 06/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/02/2021
Device Model NumberNIPG2500
Device Catalogue NumberNIPG2500
Device Lot Number9445975
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/02/2019
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: 04/05/2021 Patient Sequence Number: 1
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