Description of Event or Problem · 0
PATIENT WAS ADMITTED FOR A SURGICAL PROCEDURE ON (B)(6) 2022 TO ASSESS OPERATION OF AN INSPIRE MEDICAL SYSTEM IMPLANT (COMPONENT MODEL NUMBERS 4063, 4340, 3028 AND 2500N) DUE TO INEFFECTIVE THERAPY, WORSENING OF THE MEDICAL CONDITION THE IMPLANT WAS TO TREAT, DEVELOPMENT OF NEW AND WORSENING MEDICAL CONDITIONS, TISSUE AND NERVE INJURY, HEADACHES AND NAUSEA, SUFFERING, AND FRUSTRATION. A (B)(6) 2022 DRUG INDUCED SLEEP ENDOSCOPY (DISE) CONFIRMED THE DEVICE WAS NOT FUNCTIONING AS DESIGNED OR INTENDED. RESPIRATORY SENSING PARAMETERS WERE REPROGRAMMED DURING THE DISE PROCEDURE BY THE PHYSICIAN USING, WHICH IS NOW KNOWN TO BE, NON-STANDARD CARE. THE PATIENT MADE NUMEROUS REQUESTS TO THE SURGEON AND MEDICAL FACILITY FOR DETAILED RESULTS FROM THE PROCEDURE AND PRIOR DIAGNOSTIC PROCEDURES BETWEEN JANUARY AND MARCH 2023 DUE TO CONTINUED WORSENING OF HIS MEDICAL CONDITIONS. OVER THAT PERIOD THE SURGEON USED, WHAT IS NOW KNOWN TO BE, NON-STANDARD CARE TO REPROGRAM THE DEVICE MULTIPLE TIMES, RESULTING IN CONTINUED WORSENING OF MEDICAL CONDITIONS. DUE TO THE CONTINUED REFUSAL OF THE SURGEON AND MEDICAL FACILITY TO RELEASE DETAILED TEST RESULTS, THE PATIENT ACQUIRED A (B)(6) CLASS I POLYSOMNOGRAPHY MEDICAL LAB, SENSORS AND SOFTWARE IN (B)(6) 2023 TO ACQUIRE TEST DATA TO POSITIVELY CONFIRM THE DEVICE WAS NOT AND COULD NOT FUNCTION AS DESIRED, TO ASSESS THE EXTENT OF HIS WORSENING MEDICAL AND NEUROLOGICAL CONDITIONS AND LAY THE FOUNDATION FOR A POTENTIAL MEDICAL SOLUTION. TWO DAYS BEFORE THE PATIENT WAS SCHEDULED FOR A (B)(6) MODIFIED EXPANSION SPHINCTER PHARYNGOPLASTY IN LATE (B)(6) OF 2023 DUE TO THE WORSENING CONDITIONS, THE PHYSICIAN CALLED THE PATIENT MULTIPLE TIMES AFTER HOURS, AND REQUESTED THAT THE PATIENT ATTEMPT TO SELF-DIAGNOSE A POTENTIAL DEFECT WITH THE IMPLANT'S RESPIRATORY SENSING SYSTEM. THE PATIENT INDICATED HE COULD NOT MAKE THE SELF-DIAGNOSIS AND REQUESTED A CONSULTATION WITH THE SURGEON AND IMPLANT MANUFACTURER THE NEXT DAY. THAT REQUEST LED TO CANCELLATION OF A CRITICAL SURGERY BY THE SURGEON AND MEDICAL FACILITY AND TERMINATION OF ALL CARE RELATED TO THE IMPLANT. FURTHERMORE, THE IMPLANT MANUFACTURER REFUSED TO ACKNOWLEDGE ORAL OR WRITTEN INFORMATION FROM THE PATIENT AT THE TIME THAT WOULD POTENTIALLY PREVENT INJURY TO MORE THAN 3,000 IMPLANT PATIENTS PER YEAR WITH EXPIRATORY FLOW BLOCKAGES SUCH AS PALATAL PROLAPSE REGARDLESS OF WHETHER THEY PRE-EXISTED OR WERE CAUSED BY THE DEVICE. WHILE THE PATIENT HAS BEEN ABLE TO RE-ENGAGE WITH THE IMPLANT MANUFACTURER THROUGH AN ALTERNATIVE SURGEON AND IT WAS ACKNOWLEDGED THAT NON-STANDARD CARE WAS PROVIDED, NO ACTION HAS BEEN TAKEN BY THE IMPLANT MANUFACTURER TO SCHEDULE AGREED TO MEDICAL PROCEDURES RELATED TO THE IMPLANT (ENHANCED PSG TITRATION). FURTHERMORE, NEITHER THE SURGEON NOR THE IMPLANT MANUFACTURER HAVE REPORTED ADVERSE EXPERIENCES IN THE MAUDE DATABASE RELATED TO IMPLANT-INDUCED EXPIRATORY FLOW RESTRICTIONS/BLOCKAGES, PRE-IMPLANT SCREENING BY CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE) OR PSG (POLYSOMNOGRAPHY) FOR POTENTIAL EXPIRATORY FLOW RESTRICTIONS/BLOCKAGES RECOMMENDED BY THE PATIENT AND LOW-COST TESTS RECOMMENDED BY THE PATIENT THAT CAN BE PERFORMED TO VERIFY THAT THE IMPLANT'S RESPIRATORY SENSING SYSTEM FOR 3- OR 2-INCISION IMPLANTS IS FUNCTIONING PROPERLY TO AVOID "FREEWHEELING OF THE IMPLANT", POTENTIALLY INCREASING THERAPEUTIC BENEFIT AND MINIMIZING INJURY IN UP TO 30% OF PATIENTS (30,000/YEAR). REFERENCE REPORTS: MW5118436, MW5118437.