MAUDE Adverse Event Report: MEDTRONIC, INC. COBALT HF CRT-D MRI SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTPB2D1

Device Problems Nonstandard Device (1420); Firing Problem (4011)

Patient Problem Insufficient Information (4580)

Event Date 08/20/2022

Event Type  Injury  

Event Description

Cobalt hf crt - d 'active recall' by medtronic, inappropriate firing x6 - (b)(6) 2022.Fda safety report id# (b)(4).

• Brand Name: COBALT HF CRT-D MRI SURESCAN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 15300564
• MDR Text Key: 298832843
• Report Number: MW5111719
• Device Sequence Number: 1
• Product Code: NIK
• 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: 08/23/2022

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: DTPB2D1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Race: White