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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 LEAD2008-35B
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 08/07/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The manufacturing and sterilization records were reviewed and no issues were found related to the nature of the complaint.
 
Event or Problem Description
It was reported to nevro that the patient had an infection at the lead extension site.The system was removed and the patient was given antibiotics.Nevro attempted to obtain additional information regarding the nature of the infection but was unsuccessful.The patient continues to be under medical supervision in the hospital.
 
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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 Key8966339
Report Number3008514029-2019-00377
Device Sequence Number2100029
Product Code LGW
UDI-Device Identifier00813426020060
UDI-Public00813426020060
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 Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/05/2019
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 Date08/31/2021
Device Model NumberLEAD2008-35B
Device Catalogue NumberLEAD2008-35B
Device Lot Number94434601
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/09/2019
Initial Report FDA Received Date09/05/2019
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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