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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 TLEAD1058-70B
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Cerebrospinal Fluid Leakage (1772)
Date of Event 07/11/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The manufacturing records were reviewed and no issues were found.H3 other text : the device was not available for return.
 
Event or Problem Description
It was reported to nevro that the during the trial the patient developed symptoms from a leakage of cerebrospinal fluid.The device was removed and the patient later had a blood patch to resolve the issue.The patient has recovered without sequelae.
 
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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 Key12285224
Report Number3008514029-2021-00303
Device Sequence Number2840250
Product Code LGW
UDI-Device Identifier00813426020374
UDI-Public00813426020374
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) 08/05/2021
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 Date01/31/2024
Device Model NumberTLEAD1058-70B
Device Catalogue NumberTLEAD1058-70B
Device Lot Number94490635
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 07/11/2021
Initial Report FDA Received Date08/05/2021
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;
Patient Age50 YR
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