MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC ADVISA DR MRI SURE SCAN PACEMAKER; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number A2DR01

Device Problem Electromagnetic Interference (1194)

Patient Problems Dyspnea (1816); Dizziness (2194); Chest Tightness/Pressure (2463)

Event Date 11/13/2020

Event Type  Injury  

Event Description

Pacemaker interference.I am a (b)(6) year old male diagnosed with hypertrophic cardiomyopathy resulting in a septal myectomy performed in 1994 at the (b)(6) foundation.I have a medtronic dual chamber pacemaker initially installed in 1996 and subsequently had an av node ablation making me totally dependent on my pacemaker.My wife and i leased two (b)(6) through (b)(6) that were received on (b)(6) 2020.I was aware of the magnets in the new phones and had conversations with (b)(6), medtronic and my electrophysiologist to assure my safety.I wanted to understand how magnets interfered with implanted devices and could i safely use the (b)(6).All parties referenced (b)(6) specifications stating the phone was safe for individuals with implanted devices, but the phone should remain 6" from the implanted device.Based on these assurances, i felt comfortable ordering the new phones and i could merely move the phone to my opposite ear if i encountered any issues.While i was unpacking the phones on (b)(6) 2020 i quickly realized that the (b)(6) was interfering with my pacemaker as i experienced shortness of breath, light headedness and a pulling on my chest.I felt terrible.This sensation continued with the phone being at least 15 feet away, which is significantly more than 6".I was frustrated that i could not use the new phone but quickly realized this issue was more concerning than my use of the phone.What happens when i am in the presence of the (b)(6) in situations as follows: airplanes, elevators, crowded environments, sporting events, religious services and on and on.I can control my use of the phone, but i have no control over others using the (b)(6).As (b)(6) sales proliferate, this problem becomes a bigger issue.My wife and i have both returned our (b)(6).And felt their research did not apply to my situation.In early (b)(6) of 2021, (b)(6) issued a press release that identified issues with their new phones and implantable devices.I was informed that no other individuals had reported issues, yet (b)(6) releases a new warning.I assume there are others that are facing issues similar to mine.Based on covid restrictions, i have not been traveling or subjecting myself to crowds.I am very concerned for myself and others experiencing significant adverse effects while exposed to (b)(6).I recently had to visit my (b)(6) store and experienced significant symptoms at that time since there were several (b)(6) present.I have had my pacemaker interrogated 3x with the (b)(6) present.In all three instances, i experienced significant issues with the phone being at least 15 feet away.One time the experience was captured on the ekg, yet this is debatable.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC ADVISA DR MRI SURE SCAN PACEMAKER
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 11357998
• MDR Text Key: 233143282
• Report Number: MW5099516
• Device Sequence Number: 1
• Product Code: NVZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: A2DR01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 94