MAUDE Adverse Event Report: UNKNOWN PACEMAKER; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Device Problems Nonstandard Device (1420); Pacing Problem (1439); Device-Device Incompatibility (2919)

Patient Problem Arrhythmia (1721)

Event Date 09/08/2022

Event Type  Injury  

Event Description

I have a recalled philips bipap and have a tracheostomy.I complained to philips that i needed an escalation on my recalled device and a) they cannot give me ship date; and b) they say the dme will get the device and get it to me; but, the dme said they are not involved.How do i get a replacement device that won't shoot the stuff straight into my lungs via the trach? second issue, i have the magnetic full face masks and a permanent pacemaker and noted strange arrythmias.While in the icu, i was told by the medical staff that i should not use the full face mask since it was interfering with my pacer (i guess they noted this on the monitor) and the masks had been recalled.I have not heard anything from my dme or philips so i called philips and they told me that the masks have not been recalled.It's now rarely going to be a problem since i have a trach, but, for short periods i do cap the trach and can use the face mask so i would like a solution and neither the dme or philips is helping with either of these.Fda safety report id# (b)(4).

• Brand Name: PACEMAKER
• Type of Device: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 15542938
• MDR Text Key: 301255886
• Report Number: MW5112413
• Device Sequence Number: 2
• Product Code: MNS
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/30/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White