MAUDE Adverse Event Report: ABBOTT MEDICAL FORTIFY ASSURA; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number CD-1357-40Q

Patient Problems Shock from Patient Lead(s) (3162); Unspecified Heart Problem (4454)

Event Date 05/24/2017

Event Type  Injury  

Event Description

Reporter calling, stating his implanted defibrillator administered numerous shocks inappropriately.Reporter states he had a fortify assura implanted in (b)(6) 2017, and one morning, after brewing a pot of coffee, the device began shocking him.Reporter states his blood pressure and heart rate at the time were "normal" but the device continued to shock him repeatedly.Reporter states he called paramedics, and after they arrived and he was placed on the gurney, the device shocked him again.Reporter states the device continued shocking him during the ambulance ride to the hospital and all the way into his admission in the emergency room.Reporter states that in "(b)(6) 2018" he required cardiac ablation, and the device was eventually explanted in (b)(6) 2019, and a new device was implanted.Reporter states he is having no problems with the new device.Reporter states he received a letter from the fda (food and drug administration) about the fortify assura device being recalled, and after going to his local library and performing research, learned that the defibrillator had problems "with the batteries".Reporter states that after his device was explanted, the hospital returned "to abbott" for evaluation.Reporter states he has initiated contact with abbott numerous times, however he has received "no feedback" from them.

• Brand Name: FORTIFY ASSURA
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 17817774
• MDR Text Key: 324336216
• Report Number: MW5146135
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• 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: 09/25/2023

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 Model Number: CD-1357-40Q
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male