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

Model Number E140

Device Problem Failure to Convert Rhythm (1540)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2021

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that defibrillation threshold testing (dft) was performed on this patient due to difficulty converting the patient's arrhythmias.Normal shock impedance measurements were produced.A boston scientific technical services consultant documented and discussed the clinical observations.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: 13387354
• MDR Text Key: 284647356
• Report Number: 2124215-2022-02249
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526480713
• UDI-Public: 00802526480713
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/28/2022

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: Health Professional
• Device Expiration Date: 01/12/2017
• Device Model Number: E140
• Device Catalogue Number: E140
• Device Lot Number: 119254
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male