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

Model Number TLEAD1058-50B

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturing records were reviewed and no issues were found related to the nature of the complaint.Nevro is awaiting the return of the device.

Event Description

It was reported to nevro that during the trial lead pull procedure the most distal electrode detached from the lead into the patient, remaining subcutaneous.The patient finished the trial with effective pain relief and is planning to be implanted with an ipg, at which point the physician plans to assess if the electrode can be removed.There have been no reports of further complications regarding this event.

Manufacturer Narrative

The device was returned and analyzed.Visual inspection confirmed the most distal electrode was missing from the lead.High magnification of the wire strands showed features consistent with tensile overload failure.The cause could not be determined.

Event Description

Follow-up indicated that the patient had a permanent device implanted and the physician decided not to remove the detached electrode.

• 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 Key: 9795478
• MDR Text Key: 182784876
• Report Number: 3008514029-2020-00478
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020367
• UDI-Public: 00813426020367
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2022
• Device Model Number: TLEAD1058-50B
• Device Catalogue Number: TLEAD1058-50B
• Device Lot Number: 94455985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 03/05/2020
• Supplement Dates Manufacturer Received: 02/10/2020
• Supplement Dates FDA Received: 05/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1