MAUDE Adverse Event Report: NEVRO CORP. SENZA; NEVRO SENZA

Model Number NIPG1500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Erosion (2075)

Event Date 08/05/2019

Event Type  Injury  

Manufacturer Narrative

Nevro is awaiting the return of the device.The manufacturing records were reviewed and no non-conformities were found.

Event Description

It was reported to nevro that the skin at the ipg site was gradually eroding away.The device was removed and the patient has recovered without sequelae.It was noted that the patient was receiving effective pain relief prior to the device removal and they are looking forward to be re-implanted in the future.

Manufacturer Narrative

Visual inspection of the returned device did not find any anomaly.Functional testing was performed and the device operated to specifications.Review of the patient's diagnostic data also showed no evidence of any issues related to the nature of the complaint.The manufacturing records were reviewed and no non-conformities were found.

Event Description

The device was returned for analysis.

• Brand Name: SENZA
• Type of Device: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP.; 1800 bridge parkway; redwood city CA 94065
• MDR Report Key: 8950474
• MDR Text Key: 156129323
• Report Number: 3008514029-2019-00374
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020015
• UDI-Public: 00813426020015
• Combination Product (y/n): N
• PMA/PMN Number: P130022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2019
• Device Model Number: NIPG1500
• Device Catalogue Number: NIPG1500
• Device Lot Number: 9440458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 08/05/2019
• Supplement Dates FDA Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR