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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 Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/04/2020
Event Type  malfunction  
Manufacturer Narrative
The manufacturing records were reviewed and no issues were found.A review of the complaint record has found no other instances of similar events for this lot.The device was not available for return.
 
Event Description
It was reported to nevro that the patient felt a pop in the back when they picked up their daughter.During the removal of the device, it was found that the lead had a fracture near the anchor site.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 Key11121056
MDR Text Key226089505
Report Number3008514029-2021-00007
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 01/05/2021
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 Date08/20/2022
Device Model NumberLEAD1058-70B
Device Catalogue NumberLEAD1058-70B
Device Lot Number94455978
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/10/2020
Initial Date FDA Received01/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/20/2019
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 Age33 YR
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