FDA Adverse Event Injury Summary report: N

Stimulator, hypoglossal nerve, implanted, apnea

MDR report key: 24968442 · Received April 23, 2026

Report

Report Number
3007666314-2026-01206
Event Type
Injury
Date Received
April 23, 2026
Date of Event
April 1, 2026
Report Date
April 23, 2026
Manufacturer
INSPIRE MEDICAL SYSTEMS
Product Code
MNQ
PMA / PMN Number
P130008
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

NO IDENTIFYING INFORMATION WAS PROVIDED REGARDING THE PATIENT OR THE PATIENT¿S COMPONENTS. PUBLISHED YEAR: 2018. AUTHOR: BANSBERG SF ET AL. TITLE: SUBPECTORAL IMPLANTATION OF THE HGNS: AN EFFECTIVE TECHNICAL MODIFICATION. JOURNAL TITLE: THE LARYNGOSCOPE, DEEP ET AL.: SUBPECTORAL DEVICE PLACEMENT. VOLUME: 00:1¿4. CASE REPORT DESCRIBES A PATIENT WITH A HISTORY OF BILATERAL MASTECTOMY AND RADIATION FOR BREAST CANCER WHO REQUIRED EXPLANTATION DUE TO DEVICE EXPOSURE AND INFECTION. 67-YEAR-OLD FEMALE WITH HISTORY OF BILATERAL TOTAL MASTECTOMY AND POSTOPERATIVE CHEMORADIATION 6 YEARS PRIOR. PHYSICAL EXAMINATION REVEALED THINNING OF THE SKIN/SUBCUTANEOUS TISSUE LAYER BILATERALLY, WITH SCARRING OF THE THINNED CUTANEOUS COVERING TO THE RIB CAGE ON THE RIGHT SIDE. THE LEFT SIDE WAS CHOSEN FOR IMPLANTATION BECAUSE THERE APPEARED TO BE ADEQUATE TISSUE COVERAGE FOR THE IPG. IMPLANTATION WITH DEVICE MODEL 3024 (INSPIRE MEDICAL SYSTEMS, INC.) WAS PERFORMED IN APRIL 2016. THE THREE COMPONENTS OF THE INSPIRE SYSTEM (ACTIVATION LEAD/WIRE, IPG, SENSING LEAD/WIRE) WERE IMPLANTED WITHOUT DIFFICULTY OR COMPLICATION. THE SKIN AND SUBCUTANEOUS TISSUE LAYER OVERLYING THE IPG WAS NOTED TO BE THIN AND ATROPHIC. BOTH CHEST INCISIONS WERE COVERED WITH A LIGHT DRESSING, WHICH WAS REMOVED THE FOLLOWING DAY. THERE WERE NO WOUND ABNORMALITIES. DUSKY SKIN CHANGES WERE NOTED AT THE INFERIOR MARGIN OF THE IPG ON POSTOPERATIVE DAY 10. THIS SKIN AREA PROGRESSED TO FULL-THICKNESS NECROSIS, IMPLANT EXPOSURE, AND PURULENT DISCHARGE ON POSTOPERATIVE DAY 29 (FIG. 1). SURGICAL DEBRIDEMENT, ANTIBIOTIC IRRIGATION, AND COVERAGE OF THE IPG WITH A PECTORALIS MUSCLE FLAP WAS PERFORMED THE FOLLOWING DAY. CULTURE-DIRECTED INTRAVENOUS ANTIBIOTICS WERE ADMINISTERED FOR 3 DAYS, FOLLOWED BY ORAL ANTIBIOTIC THERAPY FOR 5 MONTHS. DURING THIS TIME PATIENT UNDERWENT DEVICE ACTIVATION AND TITRATION. TWENTY DAYS FOLLOWING DISCONTINUATION OF THE ANTIBIOTICS, THE PATIENT NOTED REDNESS, SWELLING, AND FLUID WEEPAGE AT THE SENSING LEAD INCISION. THE PATIENT WAS RETURNED TO THE OPERATING ROOM AND, ALTHOUGH THE PECTORALIS MUSCLE HAD PROTECTED THE DEVICE FROM EXTRUDING THROUGH THE ATROPHIC SKIN, PERSISTENT INFECTION WAS EVIDENT SECONDARY TO A BIOFILM INVOLVING THE IPG AND SENSING LEAD WIRE (FIG. 2). THEREFORE, ALL DEVICE COMPONENTS WERE REMOVED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
565088 Stimulator, hypoglossal nerve, implanted, apnea MNQ INSPIRE MEDICAL SYSTEMS

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Required Intervention