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
Medical Device Problem Code	Failure to Analyze Signal (1539)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11614835
• Report Number: 2184149-2021-00106
• Device Sequence Number: 3157480
• Product Code: DQK
• UDI-Device Identifier: 05415067003119
• UDI-Public: 05415067003119
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K092810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 03/27/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1