MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORIGEN EL ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	D050
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device remains implanted.Should additional information become available this investigation will be updated.
Event or Problem Description
It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis showed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.This device remains implanted.No adverse patient effects were reported.
Event or Problem Description
It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis showed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.The device was explanted, replaced and was planned be returned.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This device was planned to be returned.Upon return and analysis completion this investigation will be updated.
Event or Problem Description
It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis showed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.The device was explanted, replaced and was planned be returned.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed.Review of device memory confirmed that a low voltage alert (code 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 low voltage capacitors.Low voltage capacitors are used in the device's high voltage charging operation in order to facilitate fast charge times.Investigation has determined that the low voltage capacitors can become compromised due to the presence of excess hydrogen gas within the device case.Malfunction of these capacitors resulted in a high current drain, which was depleting this device's battery faster than normal.

• Brand Name: ORIGEN EL ICD VR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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: 14068905
• Report Number: 2124215-2022-07689
• Device Sequence Number: 17374718
• Product Code: LWS
• UDI-Device Identifier: 00802526535024
• UDI-Public: 00802526535024
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2023

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: 04/11/2020
• Device Model Number: D050
• Device Catalogue Number: D050
• Device Lot Number: 236237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 04/27/2022; 05/04/2023
• Initial Report FDA Received Date: 04/09/2022
• Supplement Report FDA Received Date: 05/25/2022; 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 47 YR
• Patient Sex: Female