MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESSENTIO EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number L121

Device Problems Defective Device (2588); Device Markings/Labelling Problem (2911)

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

Event Date 06/10/2021

Event Type  malfunction  

Event Description

It was reported that information was received regarding the advisory status of this pacemaker.The pacemaker was subsequently explanted due to an upgrade to a cardiac resynchronization therapy pacemaker (crt-p) system.The pacemaker was returned and analysis completed in our post market quality assurance laboratory determined that the device did not meet longevity expectations.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.A high current drain was detected.Detailed analysis identified a high current drain was a result of compromised capacitors, which resulted in premature battery depletion.It was determined that the capacitors were compromised due to the presence of excess hydrogen in the device case.Boston scientific issued a field safety notice in september 2018, which was expanded in june 2021, regarding a subset of devices in the accolade pacemaker family that has an elevated potential of exhibiting this behavior.This particular device is included in the hydrogen induced premature depletion advisory population.

• Brand Name: ESSENTIO EL DR
• 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: 14107295
• MDR Text Key: 289263088
• Report Number: 2124215-2022-10403
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526558986
• UDI-Public: 00802526558986
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970003/S167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2017
• Device Model Number: L121
• Device Catalogue Number: L121
• Device Lot Number: 707252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Male