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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 LEAD1058-70B
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/26/2018
Event Type  Injury  
Manufacturer Narrative

The device was not returned. The manufacturing records were reviewed and no non-conformities were found.

 
Event Description

It was reported to nevro that during the implant procedure the physician could not implant the lead due to the patient's anatomy. A leakage of cerebrospinal fluid was also noted. The procedure was aborted and there have been no reports of further complications regarding this event.

 
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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 Key8192764
Report Number3008514029-2018-00554
Device Sequence Number1
Product CodeLGW
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 12/21/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberLEAD1058-70B
Device Catalogue NumberLEAD1058-70B
Device LOT Number94421053
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/26/2018
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: 12/21/2018 Patient Sequence Number: 1
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