MAUDE Adverse Event Report: RESMED CORP. RESMED F20 CPAP MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Patient Problems Apnea (1720); Headache (1880)

Event Type  Other  

Event Description

Patient has history of sleep apnea dating back to 2016.She has been on cpap on/off since 2016.She also has history of chiari malformation and underwent a chiari decompression (b)(6) 2017 resulting in significant improvement in headaches.She was subsequently diagnosed with pseudotumor cerebri and underwent placement of lp(lumboperitoneal) shunt in (b)(6) 2019 with resolution of pressure headaches.She had a recurrence of pressure headaches and an opening pressure of 29cm water so she underwent revision of lp shunt (b)(6) 2022 for a kinked connection between the intrathecal catheter and valve.Headaches improved significantly.She was subsequently diagnosed with a migraine headache condition and was started on migraine medicines.In late 2022, she had a spinal tap that showed a marginally elevated opening pressure of 19cm h2o(water).Headaches improved following drainage and reprogramming of her shunt.She subsequently returned with pulling headache into the posterior aspect of the head and neck that began in (b)(6) 2023 and has persisted.She was sent for lumbar puncture which revealed an opening pressure of 30cm water.She got benefit from drainage of csf(cerebrospinal fluid) but headaches have returned.Csf studies were benign.Since her lp(lumboperitoneal) shunt failed once again and elevated intracranial pressures seemed to be causing headaches, lp shunt was removed and replaced with vp(ventriculoperitoneal) shunt (b)(6) 2023 which potentially can minimize the risk of kinking or other issues with valve obstruction.She has noted improvement in headaches since vp shunt was placed.Of note, her neurosurgeon has told her they are unsure why her shunt failed.Subsequently, resmed had a class i recall of their magnetic masks 11/2023 because of their interference with certain medical implants and devices, including csf shunts.Patient states she has used several types of masks dating back to 2016 but knows for sure she has used f20 mask on/off for at least the past 2 years.Therapy dates: (b)(6) 2022 - (b)(6) 2024.Reference report #mw5151070.

• Brand Name: RESMED F20 CPAP MASK
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 18649792
• MDR Text Key: 334758961
• Report Number: MW5151069
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1