MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LEFT VENTRICULAR PACEMAKER LEAD; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 354805

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock from Patient Lead(s) (3162)

Event Type  Injury  

Event Description

Was told lead had oversensing, high impedances, and noise, which resulted in inappropriate shocks at some point.When patient came in for extraction, therapies had been turned off at some point.Explanted and replaced.This report reflects information received by fda in the form of a notification per 803.22 (b) (2).Ref report: mw5119393.

• Brand Name: LEFT VENTRICULAR PACEMAKER LEAD
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 17325205
• MDR Text Key: 319119747
• Report Number: MW5119392
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 354805
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention