MAUDE Adverse Event Report: UNKNOWN LV LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 511212

Device Problems High Sensing Threshold (2574); High Capture Threshold (3266)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The device was received with paperwork that indicated that the lv lead, model(s): 511212 had high thresholds, was programmed off and capped on 2021.(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: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17535589
• MDR Text Key: 321332859
• Report Number: MW5142484
• Device Sequence Number: 1
• Product Code: DTB
• 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

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 511212
• Patient Sequence Number: 1