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

Model Number L100

Device Problems No Audible Alarm (1019); Pacing Problem (1439); Interrogation Problem (4017)

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

Event Date 10/20/2021

Event Type  Injury  

Manufacturer Narrative

This product is being evaluated in our post market quality assurance laboratory.This report will be updated when evaluation is complete.

Event Description

It was reported that interrogation of this device was unsuccessful and magnet application did not elicit tones.The device was explanted and returned for evaluation.No additional adverse patient effects were reported.

Manufacturer Narrative

This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.The device was found to have no telemetry.The device case was removed to facilitate inspection of the internal components and further testing.The battery was removed from the device and replaced with an external power source.The current drain was measured and found to be normal.Detailed analysis of the battery identified an internal short, which was caused by a tear in the cathode insulating tube.The short caused an increase in power consumption, which resulted in the reported clinical observations.Investigation into this behavior determined that the cathode tab insulation within the battery could be partially damaged during manufacturing when the insulation tube was placed over the cathode tab.The damage did not initially result in a breach of the insulation, and as a result, subsequent manufacturing verification testing performed after the battery was fully assembled was normal.Over time, the damaged insulation can degrade and eventually result in a situation where the cathode tab comes into contact with the device case, creating a shorted condition.As part of continuous improvement efforts, a design enhancement was implemented in 2018 to change the dimensions of the cathode tab.This enhancement was intended to reduce the likelihood of insulation damage when the cathode tab insulator tube was placed over the cathode tab.This particular device was manufactured prior to the design change.

Event Description

It was reported that interrogation of this device was unsuccessful and magnet application did not elicit tones.The device was explanted and returned for evaluation.No additional adverse patient effects were reported.

• Brand Name: ESSENTIO SR
• 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: 13270637
• MDR Text Key: 283966300
• Report Number: 2124215-2021-39978
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526558900
• UDI-Public: 00802526558900
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/13/2017
• Device Model Number: L100
• Device Catalogue Number: L100
• Device Lot Number: 707494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: 1-2761010883
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male