MAUDE Adverse Event Report: UNKNOWN LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 1688TC

Device Problems Fracture (1260); Ambient Noise Problem (2877)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Lead fracture and noise.(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: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17528909
• MDR Text Key: 321409992
• Report Number: MW5135838
• 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: 03/02/2022

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: 1688TC
• Patient Sequence Number: 1