MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-4 STIMULATOR SYSTEM 110V; GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE

Model Number	EP-4-04
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During an ablation procedure, the error message "ep4 is not responding - hardware is not responding" was displayed on the touch screen.The device was power-cycled; however, it did not pass the self test and returned to the main menu on the touch screen.The procedure was cancelled and there were no adverse patient consequences.Reconnecting the cables after the procedure resolved the issue.
Additional Manufacturer Narrative
No product was returned for investigation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided to abbott, the reported communication issue and cancellation could not be confirmed.

• Brand Name: EP-4 STIMULATOR SYSTEM 110V
• Common Device Name: GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 8200499
• Report Number: 2184149-2018-00211
• Device Sequence Number: 13991897
• Product Code: JOQ
• UDI-Device Identifier: 05414734208741
• UDI-Public: 05414734208741
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K092913
• 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
• Report Date (Section B): 02/12/2019

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: EP-4-04
• Device Lot Number: 6262800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 02/12/2019
• 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