MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. AMPERE RF GENERATOR II; EP GENERATOR

Model Number 100108166

Device Problem High impedance (1291)

Patient Problem Thrombus (2101)

Event Date 08/25/2020

Event Type  Injury  

Manufacturer Narrative

The results, method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 2030404-2020-00080.During an ablation procedure, the impedance on the catheter was noted to be high so ablation could not be performed.When the catheter was removed form the patient, a clotted blood was noted at the proximal poles.The catheter was replaced and the procedure was continued with no adverse consequences to the patient.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPERE RF GENERATOR II
• Type of Device: EP GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 10566156
• MDR Text Key: 207899490
• Report Number: 2184149-2020-00154
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100108166
• Device Lot Number: 5312703
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THERAPY ABLATION CATHETER; THERAPY ABLATION CATHETER.
• Patient Outcome(s): Required Intervention