MAUDE Adverse Event Report: MEDTRONIC DETECTOR AND ALARM, ARRHYTHMIA

Model Number 9529

Device Problem Pacing Problem (1439)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

This device was implanted an (b)(6) 2011 and was explanted on (b)(6) 2012.Loop showed episodes of >3 seconds pauses.Patient was upgraded to dual chamber pacemaker.The physician was dr.(b)(6) at (b)(6) medical center in (b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DETECTOR AND ALARM, ARRHYTHMIA
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17536345
• MDR Text Key: 321170618
• Report Number: MW5143233
• Device Sequence Number: 1
• Product Code: DSI
• 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: 07/13/2012

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: 9529
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1