FDA Adverse Event Injury Summary report: N

IV IMPLANTABLE PULSE GENERATOR

MDR report key: 19752290 · Received July 15, 2024

Report

Report Number
MW5157309
Event Type
Injury
Date Received
July 15, 2024
Date of Event
July 7, 2024
Report Date
July 11, 2024
Manufacturer
INSPIRE MEDICAL SYSTEM, INC.
Product Code
MNQ
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NC, US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

INSPIRE DEVICE MODEL NUMBER 3028, SERIAL NUMBER (B)(6), IMPLANTED (B)(6) 2023 RIGHT SIDED AND AWOKE FROM SURGERY WITH SEVERE RIGHT SIDED INTRACTABLE H/A 10/10 PAIN AND HOSPITALIZED UNTIL (B)(6) 2023. SENT HOME ON MULTIPLE PAIN MEDS INCLUDING OPIOIDS. ED VISIT (B)(6) 2023 FOR PERSISTENT HEADACHE, CT SCAN, SENT HOME OPIOIDS. SEVERE H/A WITH CALLS TO MD (B)(6) 2024 AND ADMITTED (B)(6) 2024 FOR SEVERE HA. WITH CONSULTS BY NEUROLOGY, PSYCH, ACUTE PAIN SERVICE. DURING THAT TIME TRIALED: OXYCODONE, HYDROMORPHONE, PREGABALIN, TIZANIDINE, KETOROLAC, ACETAMINOPHEN, DULOXETINE, TOPIRAMATE, RIMEGEPANT. ALSO ON CARBAMAZEPINE, TRAMADOL AT TIMES. MULTIPLE NERVE BLOCKS: AURICULAR TEMPORAL, TRIGEMINAL. MULTIPLE BOTULINUM TOXIN INJECTIONS. MULTIPLE IMAGING. MULTIPLE CALLS AND VISITS TO NEUROLOGISTS AND ENT. BETWEEN (B)(6) 2024 AND (B)(6) 2024, 13 SEPARATE VISITS, NEUROLOGY HEADACHE TEAM, ENT, ORAL SURGEON. ADMISSION (B)(6) 2024 FOR BEING FOUND DOWN WITH UNRESPONSIVENESS, NO CHANGE WITH NARCAN. INTUBATED, ADMITTED TO ICU. MEDICATIONS AT THAT TIME: DULOXETINE, BACLOFEN, OXYCODONE, LAMOTRIGINE, PREGABALIN. DURING HOSPITALIZATION EEG PERFORMED NEGATIVE BUT NOTED WITH TWO EVENTS SIMILAR TO HIS ADMITTING EVENT. WITH HEAD TURNED TO RIGHT, FLEXION OF ALL LIMBS WITH RIGOR, LABORED BREATHING. AMNESTIC TO THE EVENT. HE IS NOTED TO REPRODUCE SOME OF THE PAIN WITH PRESSING IN SUBMANDIBULAR SPACE. PRIOR TO THE IMPLANT OF THE DEVICE, PATIENT WAS NO MEDICATIONS AND HEALTHY. CONSIDERING EXPLANTATION. MULTIPLE IMAGING STUDIES: 7 TOTAL MRI: NECK, TMJ, BRAIN; BILATERAL DUPLEX SONOGRAPHY SUPERFICIAL TEMPORAL ARTERY TO EVALUATE GIANT CELL ARTERITIS; 6 TOTAL CT SCANS: BRAIN, TMJ, CERVICAL NECK. XRAY OF SOFT TISSUE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2165477 IV IMPLANTABLE PULSE GENERATOR STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA MNQ INSPIRE MEDICAL SYSTEM, INC. 3028

Patients

Seq Age Sex Outcome Treatment
1 45 YR Male Hospitalization ACETAMINOPHEN | BACLOFEN | CARBAMAZEPINE| DULOXETINE | HYDROMORPHONE| KETOROLAC | LAMOTRIGINE| LEAD, INSPIRE SENSING RESPIRATION ST34514| LEAD, INSPIRE STIMULATION 45 CM SD31768| OXYCODONE| OXYCODONE| PREGABALIN | PREGABALIN | RIMEGEPANT| TIZANIDINE| TOPIRAMATE | TRAMADOL