MAUDE Adverse Event Report: UNKNOWN MYOPORE BIPOPLAR; PERMANENT PACEMAKER ELECTRODE

Model Number MYOPORE 511211

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MYOPORE BIPOPLAR
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17537571
• MDR Text Key: 321369208
• Report Number: MW5144444
• 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: 01/05/2022

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: MYOPORE 511211
• Patient Sequence Number: 1