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

Model Number 7031

Device Problem Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Caller indicated that patient has been beeping for svc impedance oor multiple times.R: indicated that without patient monitor, alerts need to remain programmed on.Lead alerts will audibly tone.Recommended checking lead impedances to identify source of lead.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LEAD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17526226
• MDR Text Key: 321412680
• Report Number: MW5133166
• 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: 10/18/2021

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: 7031
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1