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

Model Number	H700169
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the premature ventricular contraction procedure, communication issues with the amplifier which could not be resolved resulted in the procedure being cancelled.There were intermittent ¿amplifier is disconnected¿ messages.There were no error messages under communication test field.The fiber optic and the media converter were replaced but the issue was not resolved and the procedure was cancelled.
Additional Manufacturer Narrative
Corrected data: a3, b5.Additional information: g1.
Event or Problem Description
Follow up report needed to include patient information and updated event description.During the premature ventricular contraction procedure, communication issues with the amplifier which could not be resolved resulted in the procedure being cancelled.The patient was on the table but prior to gaining access, it was noted there were intermittent ¿amplifier is disconnected¿ messages.There were no error messages under communication test field.The fiber optic and the media converter were replaced but the issue was not resolved and the procedure was cancelled with no adverse consequences to the patient.The procedure has been rescheduled.
Additional Manufacturer Narrative
One claris¿ amplifier 56 channel was received for evaluation.The reported event was able to be duplicated by power-on-self-test (post) sequencing.Based on the investigation and information provided to abbott, the reported event was able to be confirmed, and the root cause was attributed to the single board computer.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.
Additional Manufacturer Narrative
**udi related data quality updates only.**.

• Brand Name: WORKMATE¿ CLARIS¿ AMPLIFIER
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18356135
• Report Number: 2184149-2023-00250
• Device Sequence Number: 6408233
• Product Code: DQK
• UDI-Device Identifier: 05415067001696
• UDI-Public: (01)05415067001696(21)15792953(10)6729345
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K210392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/22/2024

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: H700169
• Device Catalogue Number: H700169
• Device Lot Number: 6729345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 12/14/2023; 01/15/2024; 06/10/2024; 07/10/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/10/2024; 02/01/2024; 06/20/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female