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

Model Number	L100
Medical Device Problem Codes	Premature Discharge of Battery (1057); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.It was reported that a request was made to have data from this device analyzed.Data analysis showed the battery appeared to be depleting more quickly than expected.Technical services (ts) recommended that the device either get replaced or have battery status re-revaluated in ninety days.This device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this pacemaker recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.It was reported that a request was made to have data from this device analyzed.Data analysis showed the battery appeared to be depleting more quickly than expected.Technical services (ts) recommended that the device either get replaced or have battery status re-revaluated in ninety days.This device remains in service.No adverse patient effects were reported.Additional information was received.The device was explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Review of device memory confirmed that a low voltage alertcode 1003) was recorded.A high current drain was detected, but the battery still supported full device function.Detailed analysis confirmed the identified high current drain was a result of compromised capacitors.This resulted in the observed 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 regarding a subset of devices in the accolade pacemaker family that have a potential of exhibiting this behavior.This particular device is included in the hydrogen induced premature depletion advisory population.
Event or Problem Description
It was reported that this pacemaker recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.It was reported that a request was made to have data from this device analyzed.Data analysis showed the battery appeared to be depleting more quickly than expected.Technical services (ts) recommended that the device either get replaced or have battery status re-revaluated in ninety days.This device remains in service.No adverse patient effects were reported.Additional information was received.The device was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: ESSENTIO SR
• Common Device Name: 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 20675215
• Report Number: 2124215-2024-71364
• Device Sequence Number: 12992493
• Product Code: LWP
• UDI-Device Identifier: 00802526558900
• UDI-Public: 00802526558900
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2025

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/12/2017
• Device Model Number: L100
• Device Catalogue Number: L100
• Device Lot Number: 707163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 01/07/2025; 04/10/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 01/10/2025; 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0367-2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male