MAUDE Adverse Event Report: ABBOTT LABS / ST JUDE MEDICAL, CARDIAC RHYTHM MGMT DIVISION CONFIRM RX ICD AND MY MERLIN APP FOR IOS; RECORDER, EENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DEFECTION)

Model Number DM3500

Device Problems Communication or Transmission Problem (2896); Device-Device Incompatibility (2919)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/12/2019

Event Type  malfunction  

Event Description

Confirm rx icd, and the my merlin app through which the confirm rx icd communicates to report collected data was known not to work with (b)(6) when it was installed in pt.As of (b)(6) 2019 nothing has been done either to acknowledge the malfunction, or to cause it to function as advertised.Fda safety report id# (b)(4).

• Brand Name: CONFIRM RX ICD AND MY MERLIN APP FOR IOS
• Type of Device: RECORDER, EENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DEFECTION)
• Manufacturer (Section D): ABBOTT LABS / ST JUDE MEDICAL, CARDIAC RHYTHM MGMT DIVISION
• MDR Report Key: 8826432
• MDR Text Key: 152543545
• Report Number: MW5088363
• Device Sequence Number: 1
• Product Code: MXC
• 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: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 95