MAUDE Adverse Event Report: MEDTRONIC RA LEAD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 6944

Device Problems Impedance Problem (2950); Protective Measures Problem (3015)

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

Event Type  malfunction  

Event Description

It was reported that the patient with the remote communicator of the cardiac resynchronization therapy defibrillator (crtd) system displayed a red call doctor icon.The patient was referred to contact their clinic regarding the red call doctor icon.Subsequently, troubleshooting efforts were performed, and the patient interrogation was successful.Upon review, it was noted that the crt-d exhibited high out-of-range pacing impedance measurements on both non-boston scientific right ventricular (rv) and right atrial (ra) leads.At this time, this lead remains in service and there were no adverse patient effects reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RA LEAD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17525064
• MDR Text Key: 321409970
• Report Number: MW5132006
• Device Sequence Number: 1
• Product Code: LWS
• 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
• Report Date: 09/14/2022

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: 6944
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1