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

Model Number E140

Device Problem Inaccurate Synchronization (1609)

Patient Problem Ventricular Fibrillation (2130)

Event Date 10/19/2022

Event Type  Injury  

Event Description

It was reported that this implantable cardioverter defibrillator (icd) delivered anti-tachycardia pacing (atp) for a ventricular tachycardia (vt).Atp accelerated the rhythm into the ventricular fibrillation (vf) zone and a shock was delivered and successfully converted the rhythm.Technical services (ts) discussed the episode with the physician and recommended further evaluation.No further assistance was requested at this time.No additional adverse patient effects were reported.This device remains in service.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

This report is being filed to correct field h6: impact codes.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) delivered anti-tachycardia pacing (atp) for a ventricular tachycardia (vt).Atp accelerated the rhythm into the ventricular fibrillation (vf) zone and a shock was delivered and successfully converted the rhythm.Technical services (ts) discussed the episode with the physician and recommended further evaluation.No further assistance was requested at this time.No additional adverse patient effects were reported.This device remains in service.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: 15687051
• MDR Text Key: 302559527
• Report Number: 2124215-2022-44062
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526480713
• UDI-Public: 00802526480713
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P960040/S235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/22/2013
• Device Model Number: E140
• Device Catalogue Number: E140
• Device Lot Number: 102852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2012
• 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: 74 YR