MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INC. INSPIRE UPPER AIRWAY STIMULATION (UAS) SYSTEM; NEUROSTIMULATION SYSTEM

Model Number	MODEL 4323
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	12/08/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted on (b)(6) 2016.The patient was post bilateral mastectomy and subsequent radiation treatment.The right side of the chest wall demonstrated more thinning of the skin and subcutaneous tissues than the left.The ipg was placed in a subcutaneous pocket on the left side, and the skin/subcutaneous layer noted to be thin.On postoperative day seven the patient presented for wound inspection and suture removal.A patch of crusted skin 1 cm in diameter was noted at the inferior margin of the implant.Over the next three weeks this area declared itself as a full thickness necrosis of skin and the implant became visible.The day following this observation the patient was brought to surgery where the ipg pocket was reopened, purulence noted, and the implant removed from the wound with sensing and stimulation wires undisturbed.The pocket was debrided of granulation and capsule tissue and irrigated with antibiotic solution.The unit was replaced into a sub pectoralis muscle pocket and secured and the wound sutured.Postoperative course was uneventful.Patient was referred to infectious disease and appropriate antibiotic therapy instituted.Implant activation and titration was performed over the ensuing weeks and patient did extremely well with uas.Oral antibiotic therapy discontinued after four months and two weeks later skin overlying implant became swollen and red and scant drainage occurred from sensing lead incision site.Patient was placed back on antibiotics and arrangements made for explantation on (b)(6).On day of explant surgery no evidence of inflammation, pain, or drainage.Ipg pocket was opened first and there was no evidence of infection.Sensing lead incision was opened next and granulation tissue and pus encountered overlying the wire leading to the sensor, but this area not contiguous with the implant pocket.Neck wound opened last and activation lead/wire removed without evidence of infection.All wounds were irrigated with antibiotic solution.Infected wound packed with medicated gauze to be advanced and removed.

• Brand Name: INSPIRE UPPER AIRWAY STIMULATION (UAS) SYSTEM
• Common Device Name: NEUROSTIMULATION SYSTEM
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS INC.; 9700 63rd ave n; suite 200; east bethel MN 55369
• MDR Report Key: 6209708
• Report Number: 3007666314-2016-00014
• Device Sequence Number: 415376
• Product Code: MNQ
• UDI-Device Identifier: 00855728005000
• UDI-Public: 00855728005000
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/28/2016

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: Physician
• Device Model Number: MODEL 4323
• Device Catalogue Number: 900-002-005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2016
• Initial Report FDA Received Date: 12/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INSPIRE MODEL 3024 IPG AND MODEL 4063 STIM LEAD
• Outcome Attributed to Adverse Event: Death; Required Intervention