MAUDE Adverse Event Report: ABBOTT MEDICAL ABBOTT INSERTABLE CARDIAC MONITOR; DETECTOR AND ALARM, ARRHYTHMIA

Model Number DM3500

Device Problems Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2023

Event Type  malfunction  

Event Description

I had an abbott lnsertable cardiac monitor, model dm3500, serial number (b)(6) placed (b)(6) 2023 to document frequency of afib.I was called a number of times by the physician's office where the procedure was done and notified that the device was reporting frequent episodes of afib.Having no symptoms (which i know is possible) and not wanting to stay on a blood thinner i sought a second opinion.His cardiologist read the stored data from the device and was very concerned that it was inaccurate.I was asked to wear an external cardiac monitor provided by bio-tel.I wore this for 3+ weeks and then returned to the cardiologist.The internal abbott device continued to show bouts of aflb while the external monitor did not show a single bout.The device from abbott is clearly defective and i do not know if this is only the unit that i am wearing or is a more generic problem.The cardiologist who placed the external monitor mentioned that his colleagues do not use abbott lnsertable cardiac monitors due to their prior experience of misleading results.I called the cardiologist who placed the monitor but his nurse defended their reading of the data.I did suggest that he call my new cardiologist to discuss these findings.

• Brand Name: ABBOTT INSERTABLE CARDIAC MONITOR
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): ABBOTT MEDICAL; 15900 valley view court; sylmar CA 91432
• MDR Report Key: 17203689
• MDR Text Key: 318010120
• Report Number: MW5118841
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIO-TEL EXTERNAL CARDIAC MONITOR
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White