MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 120 CHANNEL; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 09-1463-0120

Device Problem Failure to Analyze Signal (1539)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2021

Event Type  malfunction  

Event Description

During an atrioventricular nodal re-entrant tachycardia (avnrt) procedure, intracardiac signals were not visible when the amplifier was connected and the case was cancelled.The femoral vein was punctured and catheters were inserted and no intracardiac electrograms were noted.The system was restarted 3 times which did not resolve the issue and the procedure was postponed.Another system was used to complete the case the next day with no consequences to the patient.

Manufacturer Narrative

Additional information:g3.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 that no non-conformances were identified that are related to the reported event.Based on the information received, the cause of the reported signal issue and cancellation remain unknown.

• Brand Name: EP-WORKMATE SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 120 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: 11614835
• MDR Text Key: 243806103
• Report Number: 2184149-2021-00106
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067003119
• UDI-Public: 05415067003119
• Combination Product (y/n): N
• PMA/PMN Number: K092810
• 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: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 09-1463-0120
• Device Catalogue Number: 09-1463-0120
• Device Lot Number: 5232282
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1