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

Model Number 100082123

Device Problem High impedance (1291)

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

Event Date 07/07/2021

Event Type  malfunction  

Event Description

During a procedure, the ampere generator displayed an impedance out of range error after connection of the ablation catheter and the dip patch.The ablation catheter, dip patch and extension cable were replaced, with no resolution.The procedure was cancelled and the patient was on the table and prepped.There were no patient consequences.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be determined.

• Brand Name: AMPERE RF ABLATION GENERATOR
• Type of Device: EP GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 12174422
• MDR Text Key: 261733275
• Report Number: 2184149-2021-00226
• 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: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100082123
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1