MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-4 WORKMATECARDIAC STIMULATOR ROHS; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	100111219
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One workmate¿ claris¿ ep-4¿ cardiac stimulator was received for analysis.All mounting hardware was secured and all socketed ic (integrated circuit) components were fully seated.The stimulator was subjected to an extended test period while simulating pacing on an f5 protocol across all 4 channels followed by multiple power cycles and no anomalies were identified throughout investigation.All power on self-tests were passed successfully.Based on the information provided to abbott and the investigation performed, root cause of the self test issue and subsequent cancellation could not be conclusively determined as the returned stimulator functioned as anticipated throughout investigation with no anomalies identified.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.
Event or Problem Description
During procedure setup, the ep4 would not go through self test, and states that it is on but not responding.The system was power cycled, tried multiple self test, had channels pressed in to see if it would prompt to turn off channel before self test, but it still says ep4 is on but not responding.The procedure was cancelled.There were no adverse patient consequences.

• Brand Name: EP-4 WORKMATECARDIAC STIMULATOR ROHS
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 10295973
• Report Number: 2184149-2020-00096
• Device Sequence Number: 3065246
• Product Code: DQK
• UDI-Device Identifier: 05414734030236
• UDI-Public: 05414734030236
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K151911
• 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
• Report Date (Section B): 07/20/2020

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: 100111219
• Device Catalogue Number: H403023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/20/2020
• 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