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

Model Number SESRO1

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported that this right ventricular (rv) lead was capped and surgically abandoned due a product performance issue.A new device was implanted.No additional adverse patient effects were reported.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: 19213530
• MDR Text Key: 341495866
• Report Number: MW5154445
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2024

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?: Yes
• Device Model Number: SESRO1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention