MAUDE Adverse Event Report: SORIN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number UW28D

Device Problem Battery Problem (2885)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This l v lead was implanted on (b)(6) 2009 and was explanted on (b)(6) 2017 due to high lv threshold and was not reradiated at prior generator change causing early battery depletion for increasing thresholds.L v threshold set at 7.5@1.0 at replacement on (b)(6) 2017.New quad lead placed.The physician was dr.(b)(6) at (b)(6) hospital in (b)(6).No other information is available.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): SORIN
• MDR Report Key: 17526857
• MDR Text Key: 321277723
• Report Number: MW5133794
• Device Sequence Number: 1
• Product Code: NIK
• 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: 09/20/2017

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: UW28D
• Patient Sequence Number: 1