MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE¿ PRECISION¿ LINK SENSOR ENABLED; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H702475
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a ventricular tachycardia ablation procedure, a prolonged procedure occurred due to experiencing an error message with the system and the troubleshooting involved in order to resolve the issue.When all the equipment was connected, the precision link did not connect and the system displayed an error message.Multiple troubleshooting efforts were conducted, and lastly, when the precision link was exchanged, the issue was resolved.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One ensite precision magnetic link was received for evaluation.Evaluation testing of the device observed movement with all references and electrodes indicating passing results.The reported event was unable to be duplicated.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.Based on the investigation and information provided to abbott, the reported event was not confirmed and the root cause was undetermined.The device functioned as intended.

• Brand Name: ENSITE¿ PRECISION¿ LINK SENSOR ENABLED
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12691798
• Report Number: 2184149-2021-00331
• Device Sequence Number: 14484941
• Product Code: DQK
• UDI-Device Identifier: 05415067024756
• UDI-Public: 05415067024756
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K183128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2021

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: H702475
• Device Catalogue Number: H702475
• Device Lot Number: 5693292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• 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: 10/21/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2016
• 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: Unknown