MAUDE Adverse Event Report: ABBOTT ABBOTT ELECTROPHYSIOLOGY; RHYTHMVIEW AND FIRMAP

Device Problems False Reading From Device Non-Compliance (1228); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Event Description

The abbott electrophysiology rhythmview system combined with firmap is the only mapping system that specifically tells an operator where to ablate.The validity of this is now cast in serious doubt based on the recently announced oasis data.This system is now instructing doctors to intentionally damage the heart via ablation in areas that do not require being damaged.By making procedures take longer and instructing operators to burn the heart where it does not need to be burned, the fda is allowing a medical device to be marketed in a way that will likely result in harm and death.There is no doubt this system instructs doctors to burn the heart in a way that specifically contradicts all of the us and international society guidelines and now peer reviewed clinical trial data.

• Brand Name: ABBOTT ELECTROPHYSIOLOGY
• Type of Device: RHYTHMVIEW AND FIRMAP
• Manufacturer (Section D): ABBOTT; menlo park CA 94025
• MDR Report Key: 5662239
• MDR Text Key: 45525259
• Report Number: MW5062335
• Device Sequence Number: 1
• Product Code: MTD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other