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

Model Number 100142060

Device Problem Failure to Deliver Energy (1211)

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

Event Date 03/01/2021

Event Type  malfunction  

Event Description

During an atrioventricular node ablation procedure, the generator would not deliver radiofrequency energy and the procedure was cancelled.The generator was reset, new ablation cables were used, and a catheter exchange was attempted, but the issue remained.There were no adverse consequences to the patient.

Manufacturer Narrative

One ampere¿ rf ablation generator was received for evaluation.Visual inspection of the returned generator confirmed all connectors, switches, and labels appeared to have no physical damage.All the mounting hardware was secured.Normal wear from use was observed on the exterior chassis.The engineering evaluation was unable to confirm the field reported event.The returned generator was powered up and the unit completed the post (power on self test) successfully and the screen display came up normally.All connector ports were tested for functionality, numerous catheter codes were manually applied, various impedance & temperature values were also applied for investigation upon which all values were accurately tracked on the generator¿s display screen.Rf energy output was measured during ablation testing and no anomalies were identified throughout investigation as rf output was correctly displayed and measured over an extensive test period.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided to abbott and the investigation performed, the reported event was unable to be confirmed.The returned product functioned properly during the evaluation.No hardware abnormalities that would have resulted in the reported event were identified.

• Brand Name: AMPERE RF ABLATION GENERATOR
• Type of Device: EP GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11440038
• MDR Text Key: 245846160
• Report Number: 2184149-2021-00071
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 05415067004888
• UDI-Public: (01)05415067004888(10)5964000
• 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: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100142060
• Device Catalogue Number: H700488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1