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

Model Number E142

Device Problems Pacing Problem (1439); Failure to Convert Rhythm (1540); Inappropriate/Inadequate Shock/Stimulation (1574); Inaccurate Synchronization (1609)

Patient Problems Ventricular Fibrillation (2130); Electric Shock (2554)

Event Date 11/12/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) provided inappropriate shock therapy due to an atrial driven arrythmia.Boston scientific technical services (ts) reviewed the episodes and explained the patient experienced an atrial based tachyarrhythmia that rose the ventricular heart rate into the ventricular fibrillation (vf) zone, which triggered the icd to deliver inappropriate anti-tachycardia pacing (atp).The atrial arrythmia continued, leading to a dual tachycardia.The icd delivered several shocks that converted the ventricular rhythm temporarily; nevertheless, the atrial arrythmia continued driving a sustained 1:1 rhythm until therapy exhausted.The device operated as programed.Ts suggested optimizing the programing to avoid inappropriate therapy due to atrial driven arrythmia.No adverse patient effects were reported.The icd remains in service.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) provided inappropriate shock therapy due to an atrial driven arrythmia.Boston scientific technical services (ts) reviewed the episodes and explained the patient experienced an atrial based tachyarrhythmia that rose the ventricular heart rate into the ventricular fibrillation (vf) zone, which triggered the icd to deliver inappropriate anti-tachycardia pacing (atp).The atrial arrythmia continued, leading to a dual tachycardia.The icd delivered several shocks that converted the ventricular rhythm temporarily; nevertheless, the atrial arrythmia continued driving a sustained 1:1 rhythm until therapy exhausted.The device operated as programed.Ts suggested optimizing the programing to avoid inappropriate therapy due to atrial driven arrythmia.No adverse patient effects were reported.The icd remains in service.Additional information was received that previous episodes were observed where therapy was provided for atrioventricular nodal reentrant tachycardia (avnrt).It was noted that atp had worked most of the time however 1 event accelerated to the ventricular fibrillation (vf) zone and one had atp time out.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENERGEN ICD
• 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: 15954155
• MDR Text Key: 307504020
• Report Number: 2124215-2022-51854
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526480737
• UDI-Public: 00802526480737
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2015
• Device Model Number: E142
• Device Catalogue Number: E142
• Device Lot Number: 112635
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2013
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 67 YR
• Patient Sex: Male