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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 Problems Fracture (1260); Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/24/2020
Event Type  malfunction  
Manufacturer Narrative
Analysis of the device is currently in progress.The manufacturing records were reviewed, and no issues were found.
 
Event Description
It was reported to nevro that during a lead revision, the lead broke into two pieces.The lead was removed and replaced, however, the distal end of the lead remains in the patient.The physician was not concerned, and may perform a laminectomy in the future if the lead fragment needs to be removed.
 
Manufacturer Narrative
The device was returned and analyzed.The lead was returned without the distal end of the lead, which broke off during the removal of the lead.The root cause of the damage could not be determined.
 
Event Description
The device was analyzed.
 
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Brand Name
SENZA
Type of Device
NEVRO SENZA
Manufacturer (Section D)
NEVRO CORP.
1800 bridge parkway
redwood city CA 94065
MDR Report Key10759808
MDR Text Key213889293
Report Number3008514029-2020-00769
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00813426020046
UDI-Public00813426020046
Combination Product (y/n)N
PMA/PMN Number
P130022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/10/2020
Device Model NumberLEAD1058-70B
Device Catalogue NumberLEAD1058-70B
Device Lot Number94403213
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2020
Was the Report Sent to FDA? No
Date Manufacturer Received10/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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