MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENERGEN? ICD; Implantable Cardioverter Defibrillator (ICD)

Model Number	E141
Medical Device Problem Codes	Premature Discharge of Battery (1057); High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Battery Problem (2885)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) delivered a shock for a possible atrial fibrillation rhythm with rapid ventricular response (rvr).Low out of range shock impedance measurements were also noted.Technical services (ts) was consulted and indicated that such measurements are often indicative of an insulation issue.Additionally, delivery of a shock may adversely impact the pulse generator.As a result, ts recommended that the patient be evaluated in the clinic.No adverse patient effects were reported.This device remains in service.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: ENERGEN? ICD
• Common Device Name: Implantable Cardioverter Defibrillator (ICD)
• 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: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 24867068
• Report Number: 2124215-2026-19938
• Device Sequence Number: 9367806
• Product Code: LWP
• UDI-Device Identifier: 00802526480720
• UDI-Public: (01)00802526480720(17)150614
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Nurse
• Remedial Action: Recall,Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/02/2026

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: 06/14/2015
• Device Model Number: E141
• Device Catalogue Number: E141
• Device Lot Number: 123580
• 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: 03/25/2026
• Supplement Date Received by Manufacturer: 06/26/2026; 08/05/2026; 08/12/2026; Not provided
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 06/29/2026; 08/11/2026; 08/12/2026; 09/04/2026
• Date Device Manufactured: 06/19/2013
• 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: Other
• Patient Age: 19 YR
• Patient Sex: Male