MAUDE Adverse Event Report: UNKNOWN LV LEAD; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number 1458Q

Device Problem Output below Specifications (3004)

Patient Problem Dyspnea (1816)

Event Type  Injury  

Event Description

Caller indicated that the patient was currently hospitalized and after a device interrogation the lv lead output was changed from 4.Sv to 3.0v and capture was confirmed.The caller wanted to know if this change could be contributing to the patient bein short of breath.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LV LEAD
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17529017
• MDR Text Key: 321137588
• Report Number: MW5135946
• 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
• 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: 1458Q
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1