MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WORKMATE¿ CLARIS¿ DISPLAY PLUS AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number H700150

Device Problem Failure to Analyze Signal (1539)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

During an atrial fibrillation ablation procedure, a cancellation occurred due to intracardiac signal loss.Troubleshooting consisted of bypassing cardo, power cycling, swapping the ecg cables, checking the connection between the stimulator and amplifier, repositioning the right lead, exchanging the right leg lead patch and resetting the notch filter but the issue remained.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 procedure cancellation could not be conclusively determined.

• Brand Name: WORKMATE¿ CLARIS¿ DISPLAY PLUS AMPLIFIER
• 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: 9491397
• MDR Text Key: 176838523
• Report Number: 2184149-2019-00251
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067001245
• UDI-Public: 05415067001245
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H700150
• Device Catalogue Number: H700124
• Device Lot Number: 6018016
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other