MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENERGEN? CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

Model Number	N141
Medical Device Problem Codes	High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a retrospective review of device data it was identified that during a shock delivery, this system recorded a code 1005 indicative of high, out-of-range shock impedance measurements greater than 145 ohms.No other information was provided.This device was explanted.No adverse patient effects were reported.
Event or Problem Description
It was reported that during a retrospective review of device data it was identified that during a shock delivery, this system recorded a code 1005 indicative of high, out-of-range shock impedance measurements greater than 145 ohms.No other information was provided.This device was explanted.No adverse patient effects were reported.
Additional Manufacturer Narrative
Follow up report 1 (device evaluation): the complaint device was not returned to boston scientific; therefore, product analysis could not be performed.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.A risk review was completed and confirmed that the event of device displays error message 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.At this point, it can be concluded that unknown factors most probably contributed to the event.Conclusion code was updated to "cause not established" because the reason for the alleged observation(s) could not be determined.

• Brand Name: ENERGEN? CRT-D
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
• 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: 21861055
• Report Number: 2124215-2025-24635
• Device Sequence Number: 7917369
• Product Code: LWP
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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: 10/04/2013
• Device Model Number: N141
• Device Catalogue Number: N141
• Device Lot Number: 103128
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2012
• 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; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male