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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 TLEAD1058-50B
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Thrombosis/Thrombus (4440)
Date of Event 04/11/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The manufacturing records were reviewed and no issues were found.The device was not available for return.
 
Event or Problem Description
It was reported to nevro that the patient developed a deep vein thrombosis during the trial.The trial was ended early and the device was removed to start heparin therapy.The physicians do not believe the incident was related to the device and noted the patient has a history of clotting and needs to be on blood thinners long term.The trial was successful prior to the incident and the patient may be implanted with the permanent device in the future.
 
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Brand Name
SENZA
Common Device Name
NEVRO SENZA
Manufacturer (Section D)
NEVRO CORP.
1800 bridge parkway
redwood city CA 94065
MDR Report Key11780966
Report Number3008514029-2021-00168
Device Sequence Number3909438
Product Code LGW
UDI-Device Identifier00813426020367
UDI-Public00813426020367
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P130022
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 05/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date09/30/2023
Device Model NumberTLEAD1058-50B
Device Catalogue NumberTLEAD1058-50B
Device Lot Number94484918
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/11/2021
Initial Report FDA Received Date05/05/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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