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

Model Number H700489

Device Problem Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2019

Event Type  Injury  

Manufacturer Narrative

The investigation results will be provided in a subsequent submission.

Event Description

During an ablation procedure the generator flashed an error message and shut down.The generator was unable to be rebooted and the procedure was unable to be completed.There were no adverse consequences to the patient.

Manufacturer Narrative

This model number is not commercially available in the u.S.; however, it is similar to a device sold in the u.S.The product code and pma number listed, is the information for the similar comparator device.

Manufacturer Narrative

One ampere¿ rf ablation generator was received for evaluation.Visual inspection revealed the connectors, switches, and labels had no physical damage.All of the mounting hardware was secured.Normal wear and tear was observed on the exterior enclosure.No other visible anomalies were observed.The generator was powered up, timed in and the screen display came up properly.All the controls worked as designed.Various impedance levels were inputted using a decade box and the generator displayed the expected results.Ablation was simulated in irrigated and non-irrigated modes and the generator functioned as designed.Review of the event logs showed no unexpected shutdown.The unit was run over night and no power loss was observed.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.The reported complaint of error message and unexpected power loss could not be confirmed during the evaluation.Based on the information provided to abbott and the evaluation performed, the generator functioned as designed during the evaluation.The unit was run over night and no power loss was observed.

• Brand Name: AMPERE¿ RF ABLATION GENERATOR
• Type of Device: COMMON DEVICE NAME: EP GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 8771490
• MDR Text Key: 150403976
• Report Number: 2184149-2019-00127
• 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,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H700489
• Device Lot Number: 5599540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other