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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 MADP2008-25B
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/29/2020
Event Type  malfunction  
Manufacturer Narrative
The manufacturing records were reviewed and no issues were found related to the nature of the complaint.The device was not returned.
 
Event Description
It was reported to nevro that a fractured adapter was found during a revision procedure.The patient was not injured.The device was 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 Key10347354
MDR Text Key201517849
Report Number3008514029-2020-00658
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00813426020107
UDI-Public00813426020107
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 07/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2019
Device Model NumberMADP2008-25B
Device Catalogue NumberMADP2008-25B
Device Lot Number9437633
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2016
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 Age48 YR
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