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

Model Number	H700488
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	11/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During the procedure, the abbott personnel received an electrical shock when removing a return label from the ampere generator.The operator's finger went numb for a period of time but there was no harm to the patient or user.
Event or Problem Description
During the procedure, a staff member received an electrical shock when removing a return label from the ampere.The operator's finger went numb for a period of time but there was no harm to the patient or user.The procedure was completed with the reported generator with no adverse consequences to the patient.
Additional Manufacturer Narrative
When power was applied to the generator, normal boot up sequence was observed and all touch pad controls functioned normally with no error messages displayed.All connector ports were tested for functionality, numerous catheter codes were manually applied, various impedance and 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.An additional electrical safety test was performed upon which all test values met, or exceeded current manufacturing standards.The cause for the reported user shock could not be conclusively determined.

• Brand Name: AMPERE¿ RF ABLATION GENERATOR
• Common Device Name: EP GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 8143412
• Report Number: 2184149-2018-00195
• Device Sequence Number: 19884517
• Product Code: OAD
• UDI-Device Identifier: 05415067004949
• UDI-Public: 05415067004949
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P110016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: H700488
• Device Catalogue Number: H700494
• Device Lot Number: 6418896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 12/10/2018; 01/10/2019; 03/31/2020
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 12/13/2018; 01/14/2019; 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other