MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENERGEN? ICD; implantable cardioverter defibrillator

Model Number	E142
Medical Device Problem Codes	Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this this implantable cardioverter defibrillator (icd) delivered inappropriate anti-tachycardia pacing (atp) and seven inappropriate shocks for rapid ventricular response (rvr) over five episodes.Over 20 ventricular episodes were stored, and only two electrograms (egms) were stored.Due to the large number of events and the long durations of therapy events, device memory was full.The shock events are the highest priority, and the device start storing when a new event starts in case it ends with shocks.As a result, the previous shock events are overwritten.Technical services (ts) discussed troubleshooting options and programming considerations, such as reducing the number of stored non-sustained ventricular tachycardia (nsvt) events and no therapy events.This icd remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding event cause and resolution.At this time, no further information is available.Should additional information become available this report will be updated.This product investigation is still in progress.This report will be updated when product investigation is complete.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that this this implantable cardioverter defibrillator (icd) delivered inappropriate anti-tachycardia pacing (atp) and seven inappropriate shocks for rapid ventricular response (rvr) over five episodes.Over 20 ventricular episodes were stored, and only two electrograms (egms) were stored.Due to the large number of events and the long durations of therapy events, device memory was full.The shock events are the highest priority, and the device start storing when a new event starts in case it ends with shocks.As a result, the previous shock events are overwritten.Technical services (ts) discussed troubleshooting options and programming considerations, such as reducing the number of stored non-sustained ventricular tachycardia (nsvt) events and no therapy events.This icd remains in service.No additional adverse patient effects were reported.Additional information received reported that duration was extended to minimize the episode storage and reduce the likelihood of inappropriate therapy.This icd remains in service.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this this implantable cardioverter defibrillator (icd) delivered inappropriate anti-tachycardia pacing (atp) and seven inappropriate shocks for rapid ventricular response (rvr) over five episodes.Over 20 ventricular episodes were stored, and only two electrograms (egms) were stored.Due to the large number of events and the long durations of therapy events, device memory was full.The shock events are the highest priority, and the device start storing when a new event starts in case it ends with shocks.As a result, the previous shock events are overwritten.Technical services (ts) discussed troubleshooting options and programming considerations, such as reducing the number of stored non-sustained ventricular tachycardia (nsvt) events and no therapy events.This icd remains in service.No additional adverse patient effects were reported.Additional information received reported that duration was extended to minimize the episode storage and reduce the likelihood of inappropriate therapy.This icd remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Device technical analysis: this product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Device history record review: a review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Labeling review: review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Risk assessment: a risk review was completed and confirmed that the event of inappropriate shock was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• Brand Name: ENERGEN? ICD
• Common Device Name: implantable cardioverter defibrillator
• 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 ; +1(651)582-6168
• MDR Report Key: 25164851
• Report Number: 2124215-2026-25954
• Device Sequence Number: 10624201
• Product Code: LWP
• UDI-Device Identifier: 00802526480737
• UDI-Public: (01)00802526480737(17)150626
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/10/2026

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: 06/26/2015
• Device Model Number: E142
• Device Catalogue Number: E142
• Device Lot Number: 111465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Supplement Date Received by Manufacturer: 05/13/2026; 07/13/2026; 08/06/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 05/15/2026; 07/18/2026; 08/11/2026
• Date Device Manufactured: 06/28/2013
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 78 YR
• Patient Sex: Male