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

Model Number N141

Device Problem Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2024

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited longevity calculations from 10 months to 3 months remaining in a span of 1 month.Boston scientific technical services (ts) discussed that the device is nearing elective replacement indicator (eri) and suggested to send file for analysis to confirm but health care professional (hcp) declined.This device remains in service.No adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.The product has been received for analysis.Upon completion of the failure analysis of the complaint product, if there is any further relevant information from that review, a supplemental report will be filed.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited longevity calculations from 10 months to 3 months remaining in a span of 1 month.Boston scientific technical services (ts) discussed that the device is nearing elective replacement indicator (eri) and suggested to send file for analysis to confirm but health care professional (hcp) declined.This device was explanted.No additional adverse patient effects were reported.

• Brand Name: ENERGEN CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY 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 ; 6515826168
• MDR Report Key: 19040510
• MDR Text Key: 339336284
• Report Number: 2124215-2024-20531
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526480966
• UDI-Public: 00802526480966
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S255
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2024

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/21/2016
• Device Model Number: N141
• Device Catalogue Number: N141
• Device Lot Number: 113066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 07/02/2024
• Supplement Dates FDA Received: 07/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male