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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 LEAD1058-50B
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/27/2020
Event Type  malfunction  
Manufacturer Narrative
The manufacturing records were reviewed, and no non-conformities were found.The device was not removed.
 
Event Description
It was reported to nevro that one of the patient¿s leads had fractured.The physician believes the fracture may have happened due to the patient¿s scoliosis.There are no plans to address the issue; the physician will continue to work with the other lead.
 
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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 Key9684717
MDR Text Key182564968
Report Number3008514029-2020-00452
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00813426020022
UDI-Public00813426020022
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 02/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/12/2021
Device Model NumberLEAD1058-50B
Device Catalogue NumberLEAD1058-50B
Device Lot Number94435956
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/27/2020
Initial Date FDA Received02/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/12/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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