MAUDE Adverse Event Report: GREATBATCH MEDICAL ENPATH MYOPORE SUTURELESS MYOCARDIAL PACING LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 511212

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/29/2020

Event Type  malfunction  

Event Description

"rv polarity switch on (b)(6) 2020." lead manufactured by greatbatch med.Case: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ENPATH MYOPORE SUTURELESS MYOCARDIAL PACING LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): GREATBATCH MEDICAL
• MDR Report Key: 17536253
• MDR Text Key: 321174313
• Report Number: MW5143143
• 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: 02/02/2021

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