MAUDE Adverse Event Report: ST. JUDE MEDICAL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 7122Q

Device Problems High impedance (1291); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Following a vt ablation procedure today the rv coil impedance measurements are fluctuating with consecutive measurements between zero {dj and greater than 200ohms, unpredictably.Suggested that the lead insulation may be breached and that, although no oversensing is currently being reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17528635
• MDR Text Key: 321280923
• Report Number: MW5135565
• Device Sequence Number: 1
• Product Code: LWS
• 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: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 7122Q
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1