MAUDE Adverse Event Report: ST. JUDE MEDICAL DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number 1158T

Device Problem Impedance Problem (2950)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported to technical services on (b)(6) 2011 that this lv lead has rising impedances since (b)(6) 2011.Impedances were in the 360-400 ohms range and now have been consistently in the 900-1000 ohm range.Explained that surface area of rv coil is much larger than lv ring and so that is why impedance rises.Asked if other lead measurements are stable and they are all fine.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): ST. JUDE MEDICAL
• MDR Report Key: 17535200
• MDR Text Key: 321451635
• Report Number: MW5142099
• 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: 06/03/2011

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: 1158T
• Patient Sequence Number: 1