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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEVRO CORP. NEVRO; NEVRO SENZA
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NEVRO CORP. NEVRO; NEVRO SENZA Back to Search Results
Model Number EPMD1040
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/05/2019
Event Type  malfunction  
Manufacturer Narrative
Nevro is awaiting the return of the insertion needle.The manufacturing records were reviewed and no non-conformities were found.
 
Event Description
It was reported to nevro that the insertion needle detached from the hub during the trial procedure.The physician was able to remove the insertion needle without incident and there were no injuries to the patient.The procedure was completed with no further reports of complications and the patient had a successful trial.
 
Manufacturer Narrative
Follow-up indicated that the device was discarded and not available for return.This issue has been addressed with the manufacturer and corrective action has been implemented.Review of the severity and occurrence rate for this type of event shows that the overall risk is within acceptable limits.
 
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Brand Name
NEVRO
Type of Device
NEVRO SENZA
Manufacturer (Section D)
NEVRO CORP.
1800 bridge parkway
redwood city CA 94065
MDR Report Key8480914
MDR Text Key140917815
Report Number3008514029-2019-00117
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00818788020338
UDI-Public00818788020338
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 05/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/21/2023
Device Model NumberEPMD1040
Device Lot Number12148539
Was Device Available for Evaluation? No
Date Manufacturer Received03/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age74 YR
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