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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 LEAD1058-50B
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cerebrospinal Fluid Leakage (1772)
Event Date 12/08/2017
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 a patient experienced headaches and vomiting three days following the implant procedure. The patient was admitted to the hospital and a ct scan showed that the dura was nicked and cerebrospinal fluid was leaking. A blood patch was performed to seal the leak 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 Key7153164
MDR Text Key96003150
Report Number3008514029-2017-00368
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
Report Date 12/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/25/2020
Device Model NumberLEAD1058-50B
Device Catalogue NumberLEAD1058-50B
Device Lot Number94408272
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 Received12/08/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/25/2017
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: 12/28/2017 Patient Sequence Number: 1
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