MAUDE Adverse Event Report: BOSTON SCIENTIFIC PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 4135

Device Problem High Capture Threshold (3266)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Unstable thresholds high threshold capped on the (b)(6)2021 (b)(4).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): BOSTON SCIENTIFIC
• MDR Report Key: 17533963
• MDR Text Key: 321167255
• Report Number: MW5140866
• 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: 04/05/2021

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: 4135
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1