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

Model Number 4135 4136

Device Problems Fracture (1260); Therapeutic or Diagnostic Output Failure (3023); High Capture Threshold (3266)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

From (b)(4)"one out of the two leads is not functioning well and they want to replace it.We didn't know this until two days ago.One of the leads was not working well."the doctor thought there may be a fracture in the lead", from (b)(4)"high rv thresholds" leads manufactured by boston scientific.Case: (b)(4).Merged into (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: 17530925
• MDR Text Key: 321420932
• Report Number: MW5137841
• 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: 12/01/2020

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 4136
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1