MAUDE Adverse Event Report: PULSE GENERATOR, PERMANENT, IMPLANTABLE

Patient Problems Failure of Implant (1924); Electric Shock (2554)

Event Type  malfunction  

Event Description

It was reported that the system with a pulse generator and this right ventricular (rv) lead, were replaced due to issues with the rv lead, noise and three inappropriate shocks.The rv lead was cut and surgically abandoned.A new system was implanted at the same procedure.No additional adverse patient effects were reported.Disclaimer statement: this report reflects information received by fda in the form of a notification per 803.22 (b)(2).Ref report: mw5145468.

• Brand Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• MDR Report Key: 17720688
• MDR Text Key: 323256952
• Report Number: MW5145469
• 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: Unknown
• Type of Report: Initial
• Report Date: 07/26/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2023
• Patient Sequence Number: 1