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

Model Number 100111219

Device Problem Failure of Device to Self-Test (2937)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2020

Event Type  Injury  

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 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
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (AF-ST. PAUL); one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10295973
• MDR Text Key: 199493894
• Report Number: 2184149-2020-00096
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734030236
• UDI-Public: 05414734030236
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other