MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TELIGEN; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number E111

Device Problems Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Inaccurate Synchronization (1609)

Patient Problem Atrial Tachycardia (1731)

Event Date 06/22/2020

Event Type  Injury  

Event Description

It was reported that boston scientific technical services were contacted to evaluate episodes of anti-tachycardia pacing (atp) and shocks to determine whether it was appropriate therapy delivery.Technical services were contacted and determined that the device inappropriately provided atp which induced the patient into atrial fibrillation (af).The af was accelerated to a supraventricular tachycardia which was subsequently inappropriately treated with high voltage shocks.The supraventricular tachycardia self-terminated and the patient was stable with no additional consequences.Technical services provided programming suggestions to prevent therapy induced arrhythmias in the future.The physician elected to reprogram the device per technical services recommendations and the patient is continuing with remote monitoring.At this time, the device remains implanted and in service.

• Brand Name: TELIGEN
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 10255457
• MDR Text Key: 198304426
• Report Number: 2124215-2020-13412
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P960040/S198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/08/2012
• Device Model Number: E111
• Device Catalogue Number: E111
• Device Lot Number: 100319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 61 YR