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

Model Number E143

Device Problems Pacing Problem (1439); Inaccurate Synchronization (1609)

Patient Problems Tachycardia (2095); Discomfort (2330)

Event Date 02/04/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported in this literature review that an unknown patient received an implantable cardioverter defibrillator (icd) due to acute decompensated heart failure and paroxysmal atrial fibrillation (af).Several years post implant, this patient started a anti arrhythmic medication for symptomatic episodes of af.Ultimately, this patient underwent a radiofrequency (rf) ablation due to persistent symptoms of af.The medication was restarted post ablation, due to an episode of atrial tachycardia.The lower rate limit was increased at that time.During this patients hospitalization admission for the rf ablation, initial 12-lead electrocardiogram revealed an atrial paced rhythm at 70 beats per minute, inferior infarction, and a left bundle branch block morphology with qrs widening and associated repolarization abnormalities.Several episodes of a ventricular paced rhythm were noted along with episodes of atrial tachy response (atr) mode switch from af with rapid ventricular response were observed, initiated by atrial pacing in the vulnerable period during episodes of repetitive nonreentrant ventriculoatrial synchrony (rnrvas).High atrial rate episodes due to af were detected over the course of 2 months.This icd was reprogrammed and the medication, stopped.This patient did not experience any more symptomatic episodes of af, and an interrogation revealed no recurrences of atr mode switch episodes.It is assumed that this unknown icd remains in service.No adverse patient effects were reported.

• 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; saint paul 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15916486
• MDR Text Key: 304814780
• Report Number: 2124215-2022-50697
• Device Sequence Number: 1
• Product Code: LWP
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/05/2022

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 Model Number: E143
• Device Catalogue Number: E143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2022
• Initial Date FDA Received: 12/05/2022
• 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
• Patient Outcome(s): Other