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); Inaccurate Synchronization (1609)

Patient Problem Atrial Fibrillation (1729)

Event Date 10/12/2021

Event Type  Injury  

Manufacturer Narrative

If additional information is received, a supplemental report will be filed at that time.

Event Description

It was reported that the patient with this implantable cardioverter defibrillator experienced an arrhythmia.Boston scientific technical services reviewed and noted it was possibly sinus tachycardia.Anti-tachycardia pacing (atp) was provided which was noted to have possibly accelerated to atrial fibrillation (af).Additional atp episodes were provided which did not convert the af.Ts noted pacing inhibition due to the af.Ts discussed programming options.The device remains in service.No additional 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 CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 13048942
• MDR Text Key: 282550036
• Report Number: 2124215-2021-33258
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2016
• Device Model Number: E142
• Device Catalogue Number: E142
• Device Lot Number: 117757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2014
• 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
• Patient Age: 55 YR
• Patient Sex: Male