MAUDE Adverse Event Report: NEVRO CORP. SENZA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	NIPG1500
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Purulent Discharge (1812); Erythema (1840); Necrosis (1971); Pain (1994); Swelling (2091)
Date of Event	07/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Female with a history of chronic low back pain with radiation to bilateral lower extremities (le).She had a spinal cord stimulator implanted approximately 2 weeks prior to this event date.About 3 days ago she has noticed drainage and redness around her implantable pulse generator (ipg) pocket.She also feels "a hard knot" over the mid surgical scar.She reports no fever or chills.Patient came in on a work in appointment at our office today due to her concerns.The area of ipg looks red and necrosing with severe tenderness to touch.A revision was discussed and she wishes to proceed.Skin examination of the surgical wounds reveal erythema and necrosing tissue over the ipg surgical mid line.There is mild swelling with severe tenderness to palpation.Skin is warm to touch.Examination of posterior mid line surgical scar reveals no redness noted.The wound is dried and cleaned.No skin traction redness indicative of leads infection noted.Assessment: lumbar radiculopathy: failed back surgery syndrome.Possible infected ipg site.For spinal cord stimulator ipg removal with possible leads removal.Plan: revise spinal cord stimulator.Preop dx: infection at ipg and lumbar incision site.Lumbar degenerative disc disease.Postop dx: same.Procedure: explantation of implantable pulse generator as well as dual leads.Technique: patient was properly identified by me.After discussing the risks, benefits, and alternatives to the procedure, patient verbalized understanding and was willing to proceed.Informed consent was obtained and signed and the patient was given 2 grams of ancef pre-operatively.The patient was then brought to the procedure room and placed in the prone position on the c-arm table.The operative area was prepped and draped in the routine standard sterile manner.At this time after anesthetizing the prior 2 incisions, an incision was made at the prior thoracolumbar site.This was dissected down to the level of the anchors.Purulent cloudy fluid was encountered and drained.The leads were released and removed tip intact, without any difficulty.The leads were cut at this level.Attention was drawn to the ipg site.This was anesthetized locally.An incision was made and dissected down to the generator.Once again cloudy, purulent fluid was encountered and drained.Culture swabs were taken from both incision sites and sent to pathology.The ipg was removed en bloc.Both wounds were aggressively scrubbed with hibiclens sponges and irrigated with hibiclens infused solution with a wound debridement system and bacitracin solution.Elliptical incisions were made over each previous incision cutting out all nonviable tissue.The wounds were then closed in layers using 3 and 4-0 vicryl sutures for deep fascia and subcuticular closure, respectively.Mastisol, steri-strips, 4x4 and tegaderm occlusive patches were placed on each incision.Patient tolerated the procedure well with no complications.

• Brand Name: SENZA
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): NEVRO CORP.; 1800 bridge pkwy; redwood city CA 94065
• MDR Report Key: 6852142
• Report Number: 6852142
• Device Sequence Number: 17588984
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2017
• Report Date (Section F): 07/25/2017

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: No Information
• Device Expiration Date: 11/24/2018
• Device Model Number: NIPG1500
• Device Catalogue Number: NIPG1500
• Device Lot Number: 9438621
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 79
• Date Report Sent to FDA: 07/25/2017