MAUDE Adverse Event Report: ST. JUDE MEDICAL PACEL BIPOLAR PACING CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Model Number	401771
Medical Device Problem Code	Loss of Threshold (1633)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	09/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are 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.Based on the information received, the cause of the reported pacing issue could not be conclusively determined.
Event or Problem Description
On (b)(6) 2021, the patient was admitted to the emergency department due to battery depletion of the original pacemaker and temporary pacing using a temporary pacemaker was considered.During the implantation of the temporary pacemaker, the appropriate pacing position in the right ventricle could not be found and the pacing threshold was significantly increased.The issue was not resolved after searching for the appropriate potential multiple times.Following the temporary pacing implantation, the patient was noted to be poorly driven by pacing and was returned to the catheterization laboratory to adjust the electrode position, during which cardiac arrest occurred at one time and was treated by utilizing cardiopulmonary resuscitation.On september 12, the patient underwent an emergency permanent pacing implantation again due to increased threshold because the temporary pacemaker could not be driven.The permanent pacing electrode had a good threshold and a good position.The patient was noted to be in a stable condition.

• Brand Name: PACEL BIPOLAR PACING CATHETER
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• MDR Report Key: 12715002
• Report Number: 2182269-2021-00079
• Device Sequence Number: 4240068
• Product Code: LDF
• UDI-Device Identifier: 05414734001137
• UDI-Public: 05414734001137
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 401771
• Device Catalogue Number: 401771
• Device Lot Number: 7445561
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention