MAUDE Adverse Event Report: BIOTRONIK RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DETECTION)

Model Number 03

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that this device migrated to the armpit.The patient underwent a surgical intervention to remove the device and implant a new insertable cardiac monitor (icm).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: RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DETECTION)
• Type of Device: RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DETECTION)
• Manufacturer (Section D): BIOTRONIK
• MDR Report Key: 17537377
• MDR Text Key: 321168401
• Report Number: MW5144255
• Device Sequence Number: 1
• Product Code: MXC
• 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: 12/06/2021

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: 03
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1