MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number 4194

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 11/23/2011

Event Type  Injury  

Event Description

This lead was implanted on (b)(6) 2007 and was capped on (b)(6) 2011.Patient had diaphragmatic stimulation in various configurations.The physician was dr.(b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MEDTRONIC
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17517426
• MDR Text Key: 321052694
• Report Number: MW5124375
• Device Sequence Number: 1
• Product Code: LWP
• 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: 12/06/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 4194
• Patient Sequence Number: 1