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

Model Number	H700162
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During device preparation for an atrial fibrillation procedure with a patient involved, there was a communication issue with the ep-4 stimulator cable, resulting in cancellation of the procedure.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6, h11.The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported communication issue and subsequent cancellation could not be determined.

• Brand Name: EP-4¿ STIMULATOR CABLE
• 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20226936
• Report Number: 2184149-2024-00158
• Device Sequence Number: 3470056
• Product Code: DQK
• UDI-Device Identifier: 05414734030236
• UDI-Public: 05414734030236
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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: H700162
• Device Catalogue Number: H700162
• 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: 08/23/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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