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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 (2993)
Patient Problem Incontinence (1928)
Event Date 07/14/2020
Event Type  Injury  
Manufacturer Narrative
The manufacturing records were reviewed and no issues were found.The device was not available for return.
 
Event Description
It was reported to nevro that the patient's leads migrated, which may have contributed to a loss of bowel and bladder control.The leads were replaced and there have been no reports of further complications regarding this event.
 
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Brand Name
SENZA
Type of Device
NEVRO 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 Key10403579
MDR Text Key202782869
Report Number3008514029-2020-00674
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00813426020046
UDI-Public00813426020046
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 Non-Healthcare Professional
Type of Report Initial
Report Date 08/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/04/2022
Device Model NumberLEAD1058-70B
Device Catalogue NumberLEAD1058-70B
Device Lot Number94461788
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age43 YR
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