MAUDE Adverse Event Report: MEDTRONIC, INC. AMPLIA; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTMB1QQ

Device Problems Premature Discharge of Battery (1057); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Defective Component (2292)

Patient Problems Arrhythmia (1721); Failure of Implant (1924); Shock from Patient Lead(s) (3162)

Event Date 03/03/2018

Event Type  Death  

Event Description

My name is (b)(6), (b)(6) wife who died on (b)(6) 2020.(dob (b)(6) 1958).He had a pacemaker defibrillator by medtronic put in in 2018.In (b)(6) 2020 he was hospitalized because of a foot injury and ended up having irregular heart rate, and then it was just a nightmare from there, they transferred him to icu and he was in the icu for i believe a month before he died at which time his pacemaker defibrillator never did perform the way it should.It went off when it shouldn't and when it should have it did not.The battery expectancy we were told was going to be seven years , it was down two weeks! and it had only been two years.The night he passed away, it gave him no heart, therapy or shock.It did not perform at all.We had the suspicion weeks before his demise.It was working improperly, and even the field agent and the surgeon thought the same thing, but the field rep said it was just fine.Well, apparently it wasn't just fine, it had been interrogated twice.During his hospital, stay, this day was horrific and brutally unnecessary, in my own research i have found that one of the leads was defective, and the battery depletion was absurd.The device was not pacing right, it was shocking him, and needlessly at times just damaging his already weak heart, more and more, and when it should shock him like on the night of his death, it didn't at all.His own surgeon is the one who called the field.Rep out to check out the device probably a week before he died , but we were told it was just fine.In case you're wondering why it's been three years since you received this letter, well, believe me, it's not at all that i haven't tried to prove the device was defective.It's just that every time you send your information to one spot it takes forever for them to get back to you and then to another spot and then you said send it certified mail to the doctors in the hospital and the nurses and they won't even sign for the letter.Not to mention, i was grief stricken for at least the first year and still miss him horribly.Between a faulty battery, and a bad lead, and then ignored replacement that should've happened.It's no wonder i don't have a husband.Four thousand words is not enough for me to explain to you the unnecessary inhumane, and horrific death my husband had to go through, and leave me a widow.Medtronic said they investigated but they did not.I also had the device and have had the device since my husband was taken to the funeral parlor where an attorney from the family went and picked it up and stored it for me for many months.Well, in his possession, that thing went off sporadically, and i'm sure it shouldn't have been.Medtronic never once requested it from me so what did they investigate? nothing.I hope you please do your job and take heed to what i am saying! i have sent letters to the hospital and to the doctors and the surgeon, all who want to dismiss my husbands life, right along with medtronic.I hope you don't do the same.(b)(6) wasn't just a number for them to get rich off of he was my husband of 30+ years, father of our four children, and papa of six.He should have never died that hospital stay! please do not file this in your trash can, but consider it as one of your family members.I can be reached at (b)(6), which is his oldest daughter's number, (b)(6), please do the right thing and take this matter seriously and do the right thing? (b)(6).Sincerely, mrs (b)(6).

Event Description

Additional information received for report mw5145180 on 09/12/2023 to correct brand name to amplia.

• Brand Name: AMPLIA
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 17690921
• MDR Text Key: 322822267
• Report Number: MW5145180
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DTMB1QQ
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Race: White