MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. IMPLANTED PULSE GENERATOR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

Ipg (implanted pulse generator) was replaced due to elective replacement indicator (eri).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: IMPLANTED PULSE GENERATOR
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP.
• MDR Report Key: 18057662
• MDR Text Key: 327308586
• Report Number: MW5147646
• 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: 10/16/2023

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/01/2023
• Patient Sequence Number: 1