MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-4¿ CARDIAC STIMULATOR; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	EP-4-04
Medical Device Problem Codes	Pacing Problem (1439); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the supraventricular tachycardia procedure, pacing and impedance issues resulted in the procedure being abandoned with no reported adverse patient consequences.It was noted that the pacing spike was not being delivered properly to the tissue.The pacing spike was visible on the non-abbott system (cardiolab), but there was no response from the tissue.The touchscreen showed an impedance error and "check outputs switches" error.The procedure was not able to be completed and therefore abandoned.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g1, g3, g6, 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.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: EP-4¿ CARDIAC STIMULATOR
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17256219
• Report Number: 2184149-2023-00133
• Device Sequence Number: 17613626
• Product Code: DQK
• UDI-Device Identifier: 05414734208741
• UDI-Public: 05414734208741
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K092913
• 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
• Report Date (Section B): 07/12/2023

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: EP-4-04
• Device Catalogue Number: EP-4-04
• Device Lot Number: 8516633
• 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: 06/09/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• 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