MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II STEROX; PERMANENT PACEMAKER ELECTRODE

Model Number 4457

Device Problems Pacing Problem (1439); Connection Problem (2900)

Patient Problem Cardiac Arrest (1762)

Event Date 03/02/2020

Event Type  Injury  

Manufacturer Narrative

This product has not been returned; therefore, a technical analysis cannot be conducted.Without a returned product it is not possible to definitively confirm how this product may have contributed to the complaint incident.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that the patient with this system presented post non cardiac surgical procedure, with a 12 second recorded cardia arrest.Reportedly, the implanted system was checked after the procedure with no anomalies observed; however, the ecg monitoring showed poor pacing and sensing.The physician elected to reprogram the system to increase outputs but the observations continued.During a subsequent surgical intervention, it was concluded the lead was malfunctioning and it was replaced.The chronic lead was surgically abandoned.

• Brand Name: FINELINE II STEROX
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; RQ 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9946951
• MDR Text Key: 187195895
• Report Number: 2124215-2020-06170
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00802526060915
• UDI-Public: 00802526060915
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P960004/S014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/22/2018
• Device Model Number: 4457
• Device Catalogue Number: 4457
• Device Lot Number: 817990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2020
• Initial Date FDA Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention