MAUDE Adverse Event Report: MEDTRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 6943

Device Problems Low Sensing Threshold (2575); No Pacing (3268)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported to technical services on (b)(6) 2013 that this rv lead has low sensing and high pacing thresholds.Dfts had no drop out, "worked out fine".They are working with dr.(b)(6) at ahn.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: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17517655
• MDR Text Key: 321283987
• Report Number: MW5124603
• 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: 05/24/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 6943
• Patient Sequence Number: 1