MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 56 CHANNEL; PROGRAMMABLE DIAGNOSTIC COMPUTER

Model Number 09-1462-0056

Device Problem Failure to Analyze Signal (1539)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2019

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 pacing there was no signal displayed on the live screen when the catheter was connected to the pin box.All connections were checked and cabling was replaced, but the issue remained.The procedure was cancelled and there were no adverse consequences to the patient.

Event Description

During pacing there was no signal displayed on the live screen when the catheter was connected to the pin box.All connections were checked, and cabling was replaced, but the issue remained.The procedure was cancelled and there were no adverse consequences to the patient.During further troubleshooting, it was found that the system reference cable going into the amplifier was loose.Once that was tightened, the issue was resolved.

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 was due to a loose cable.

• Brand Name: EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 56 CHANNEL
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 9086651
• MDR Text Key: 159138850
• Report Number: 2184149-2019-00172
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067003126
• UDI-Public: 05415067003126
• 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: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 09-1462-0056
• Device Lot Number: 4960831
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other