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

Model Number DTMB1QQ

Device Problems Nonstandard Device (1420); Defibrillation/Stimulation Problem (1573)

Patient Problem Cardiac Arrest (1762)

Event Date 05/16/2021

Event Type  Injury  

Event Description

In 2016 i was diagnosed with heart failure and the doctors at the time told me i needed a pacemaker/defibrillator medically installed because my ejection fraction was below 20 percent and i could die by sudden cardiac arrest without it.The doctors installed a medtronic pacemaker/defibrillator that i later just this year found that was on the fda recall list.My serial number is listed on there for the battery not functioning properly.They knew this as of (b)(6) 2021 and did not tell me or warn me that i may need a replacement unit because of the problem they found and the unit may not function when needed.On (b)(6) at 8:12 pm i found out the hard way that the device did not work as i had a sudden cardiac arrest and the device did not fire.My heart stopped and if my wife would not have been there when i passed out to call 911 and perform cpr i wouldn't be here today.Fda safety report id # (b)(4).

• Brand Name: IMPLANTABLE PACEMAKER DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 12324992
• MDR Text Key: 266963086
• Report Number: MW5103254
• Device Sequence Number: 1
• Product Code: NIK
• 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: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DTMB1QQ
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 113