MAUDE Adverse Event Report: MEDTRONIC PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 1501

Device Problems Nonstandard Device (1420); High Capture Threshold (3266)

Patient Problem Syncope/Fainting (4411)

Event Type  Injury  

Event Description

This device was implanted on (b)(6) 2007 and was explanted on (b)(6) 2012 due to advisory/recall.Patient had been having syncopal episodes.The physician suspected vt but was not able to induce vt.He then suspected that the device, in combination with high thresholds in the rv, could be the issue.The physician was dr.(b)(6) at (b)(6) center in mishawaka, in.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17532429
• MDR Text Key: 321137931
• Report Number: MW5139337
• Device Sequence Number: 1
• Product Code: NVZ
• 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: 08/10/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1501
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1