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

Model Number 401770

Device Problems Pacing Problem (1439); Material Deformation (2976)

Patient Problems Cardiac Arrest (1762); Heart Block (4444)

Event Type  Injury  

Event Description

Related manufacturing ref: 2182269-2022-00044.The patient was admitted due to planned surgery for rectal cancer.He had hyperlipidemia and type 2 diabetes mellitus, and preoperative electrocardiography showed sinus rhythm and left bundle branch block (lbbb).Because of combined lbbb, the patient received temporary cardiac pacing (6f bpc 401770, abbott, usa) before surgery, and 2 days after surgery, the patient's heart rate suddenly decreased to 30 beats/min, with intermittent loss of capture of pacing and long intermittent cardiac arrest.The patient was re-admitted to the catheterization laboratory for planned coronary angiography and re-implantation of a temporary pacing electrode.Fluoroscopy showed displacement of the temporary pacing lead from the right ventricular apex to the proximal right ventricular septum, an anatomically right bundle branch distributed area.Because of temporary pacing electrode dislocation, mechanical injury to the right bundle branch caused the right bundle branch block, which resulted in a complete (third degree) atrioventricular block on the basis of pre-existing lbbb.Seven days after the operation, the patient experienced temporary pacing lead dislocation again and intermittent loss of pacing capture.Note: per the ifu, temporary pacing leads which are indwelling for extended periods of time (greater than 72 hours) should be routinely evaluated and replaced as needed.

Manufacturer Narrative

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 incident could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

Manufacturer Narrative

The health impact code was updated to surgical intervention rather than resuscitation due to event not detailing resuscitation measures taking place.

• Brand Name: PACEL BIPOLAR PACING CATHETER
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15610580
• MDR Text Key: 301814306
• Report Number: 2182269-2022-00043
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K152784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 401770
• Device Catalogue Number: 401770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PACEL BIPOLAR PACING CATHETER
• Patient Outcome(s): Other