MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE¿ EP-4¿ CARDIAC STIMULATOR, 4 CHANNEL; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 09-1527-0000

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2019

Event Type  Injury  

Manufacturer Narrative

The results, method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During the procedure, the ep-4 stimulator would not communicate with the workmate system.The stimulator was directly connected to the workstation with a serial cable.The stimulator settings were checked and it was selected under ¿stimulator¿.Replacing the serial cable and restarting the system did not resolve the issue.The procedure was cancelled and there were no adverse patient consequences.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: EP-WORKMATE¿ EP-4¿ CARDIAC STIMULATOR, 4 CHANNEL
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 9409364
• MDR Text Key: 169017160
• Report Number: 2184149-2019-00239
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734030236
• UDI-Public: 05414734030236
• Combination Product (y/n): N
• PMA/PMN Number: K151911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 09-1527-0000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other