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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 ACCK5300
Device Problem Fracture (1260)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/26/2021
Event Type  malfunction  
Manufacturer Narrative
Nevro is awaiting the return of the device.The manufacturing records were reviewed and no issues were found.
 
Event Description
It was reported to nevro that during a revision procedure the physician discovered the anchor had broken.The device was removed and replaced.There have been no reports of further complications regarding this event and the patient continues to use their device to find effective pain relief.
 
Manufacturer Narrative
Analysis of the device confirmed a tear at the suture loops.The root cause of the damage could not be determined.
 
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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 Key12022075
MDR Text Key257149305
Report Number3008514029-2021-00217
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00813426020251
UDI-Public00813426020251
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,Followup
Report Date 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/30/2022
Device Model NumberACCK5300
Device Catalogue NumberACCK5300
Device Lot Number9445507
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2021
Was the Report Sent to FDA? No
Date Manufacturer Received05/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/30/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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