MAUDE Adverse Event Report: UNKNOWN RV LEAD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 7120-65

Device Problem Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported by the patient that their device has been alerting every two hours.This is potentially indicative of a right ventricular (rv) lead issue.The lead remains in use.No patient complications have been reported as a result of this event.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RV LEAD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17535757
• MDR Text Key: 321406872
• Report Number: MW5142651
• 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: 12/01/2021

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: 7120-65
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1