MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE¿ X EP SYSTEM SURFACELINK MODULE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-SRFLNK-I-01
Medical Device Problem Codes	Communication or Transmission Problem (2896); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturer ref: 2184149-2021-00339, 3008452825-2021-00509.During a ventricular tachycardia procedure, a prolonged procedure occurred due to a "surface electrode impedance error" message displaying while puncturing the inguinal region in voxel mode, the body surface ecg 12 no longer displaying, and the troubleshooting involved in order to resolve the issue.Ultimately the system and the patches were replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6 the results of the investigation were 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 associated with the reported event were identified.Based on the information received, the cause of the reported incident could not be determined.

• Brand Name: ENSITE¿ X EP SYSTEM SURFACELINK MODULE
• 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: 12770262
• Report Number: 2184149-2021-00340
• Device Sequence Number: 3343109
• Product Code: DQK
• UDI-Device Identifier: 05415067033611
• UDI-Public: (01)05415067033611(10)788110001
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K202066
• 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): 11/29/2021

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: ENSITE-SRFLNK-I-01
• Device Catalogue Number: ENSITE-SRFLNK-01
• Device Lot Number: 788110001
• Was Device Available for Evaluation?: No
• 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: 10/22/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENSITE X EP SYSTEM SURFACE ELECTRODE KIT ; ENSITE X EP SYSTEM AMPLIFIER
• Patient Age: 83 YR
• Patient Sex: Male