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

Model Number H700488

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 11/06/2020

Event Type  Injury  

Event Description

During an atrial fibrillation procedure for pulmonary vein isolation, a patient burn occurred on the lower back.It is unknown if any intervention was administered to treat the burn.

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 that no non-conformances were identified that are related to the reported event.Based on the information received, the cause of the reported burn remains unknown.

• Brand Name: AMPERE RF ABLATION GENERATOR
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11222298
• MDR Text Key: 228398978
• Report Number: 2184149-2021-00019
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 05415067004888
• UDI-Public: 05415067004888
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H700488
• Device Catalogue Number: H700488
• Device Lot Number: 5660313
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 135