MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC; RIGHT VENTRICULAR LEAD

Model Number 0185

Device Problems Fracture (1260); Invalid Sensing (2293); Device Operates Differently Than Expected (2913)

Patient Problem Failure of Implant (1924)

Event Date 07/17/2017

Event Type  Injury  

Event Description

On (b)(6)2017, the rv lead was capped and abandoned due to the fact that it stopped functioning properly.This was found during routine f/u and manifested itself in the form of no capture and noise sensing as intermittent out of range impedance measurements.All of these findings are consistent with lead fracture.The pt did not have any adverse events related to this issue.

• Brand Name: BOSTON SCIENTIFIC
• Type of Device: RIGHT VENTRICULAR LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 6739777
• MDR Text Key: 81111195
• Report Number: MW5071185
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0185
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 75