MAUDE Adverse Event Report: SORIN UNKNOWN; PERMANENT PACEMAKER ELECTRODE

Model Number UNKNOWN

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Boston scientific received information stating the lead exhibited rv noise, oversensing, and a possible connection issue.(b)(6)hospital japan dr.(b)(6).No implant or explant dates available.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: UNKNOWN
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): SORIN
• MDR Report Key: 17519097
• MDR Text Key: 321324920
• Report Number: MW5126045
• Device Sequence Number: 1
• Product Code: DTB
• 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: 11/03/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: UNKNOWN
• Patient Sequence Number: 1