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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 NIPG1000
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 06/19/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device was not explanted.The manufacturing records were reviewed and no non-conformities were found.
 
Event or Problem Description
It was reported to nevro that during an ipg revision procedure, dark grey soft tissue was found inside the pocket site.The physician removed the tissue and proceeded to reposition the ipg at the new pocket site.No tests were performed on the tissue.There were no prior reports before the revision.Nevro had attempted to obtain additional information regarding the nature of the tissue but was unsuccessful.The patient has recovered without sequelae.
 
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Brand Name
SENZA
Common Device Name
NEVRO SENZA
Manufacturer (Section D)
NEVRO CORP.
1800 bridge parkway
redwood city CA 94065
MDR Report Key7692698
Report Number3008514029-2018-00319
Device Sequence Number14114448
Product Code LGW
UDI-Device Identifier00813426020008
UDI-Public00813426020008
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P130022
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date10/02/2015
Device Model NumberNIPG1000
Device Catalogue NumberNIPG1000
Device Lot Number9430979
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/19/2018
Initial Report FDA Received Date07/16/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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