MAUDE Adverse Event Report: ST. JUDE MEDICAL DETECTOR AND ALARM, ARRHYTHMIA

Model Number DM3500

Device Problem Product Quality Problem (1506)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

It was reported that the product was explanted due to dissatisfaction with the product.No additional adverse patient effects were reported.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): ST. JUDE MEDICAL
• MDR Report Key: 17532515
• MDR Text Key: 321407536
• Report Number: MW5139423
• 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: 04/27/2022

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: DM3500
• Device Lot Number: 33022957
• Patient Sequence Number: 1