MAUDE Adverse Event Report: MEDTRONIC CLARIA MRI QUAD CRT-D DF1; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTMA1Q1

Device Problems Break (1069); High impedance (1291); Difficult to Insert (1316); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported, that during a device replacement.The right ventricular (rv) lead was difficult to insert into the header of this non boston scientific device.The system presented noisy signals and high impedances within normal limits.A month later the physician decided to remove the device and replace it with a cardiac resynchronization therapy defibrillator (crt-d).During this replacement, the rv lead exhibited terminal end damage.And the pin lead was difficult to insert into the header.The physician noted, the proximal sealing ring was damaged, and was able to remove it.Furthermore, the lead was fully inserted into the header without issues.The rv lead remains in service.No additional adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CLARIA MRI QUAD CRT-D DF1
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17526897
• MDR Text Key: 321433399
• Report Number: MW5133834
• 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: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: DTMA1Q1
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1