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

Model Number	N140
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Defibrillation/Stimulation Problem (1573); Delayed Charge Time (2586)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) visited the emergency room (er) after reporting they had received six shocks.Upon interrogation it was noted that the device recorded a code 1007 triggered indicative of capacitor charge time exceeding limitations.The charge time was found to be greater than 45 seconds.It was further noted that this crt-d had reached elective replacement indicator (eri) battery status approximately three months prior.Technical services (ts) was consulted and recommended device replacement as therapy could not be guaranteed, as well as a review of the associated right ventricular (rv) lead integrity at during replacement.This crt-d remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) visited the emergency room (er) after reporting they had received six shocks.Upon interrogation it was noted that the device recorded a code 1007 indicative of capacitor charge time exceeding limitations.The charge time was found to be greater than 45 seconds.It was further noted that this crt-d had reached elective replacement indicator (eri) battery status approximately three months prior.Technical services (ts) was consulted and recommended device replacement as therapy could not be guaranteed, as well as a review of the associated right ventricular (rv) lead integrity at during replacement.This crt-d remains in service.No adverse patient effects were reported.Additional information was received, this crt-d was explanted and successfully replaced, however, it has not returned to boston scientific for further analysis.

• Brand Name: ENERGEN CRT-D
• Common Device Name: 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: 20317366
• Report Number: 2124215-2024-60511
• Device Sequence Number: 8147026
• Product Code: LWP
• UDI-Device Identifier: 00802526480959
• UDI-Public: 00802526480959
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/29/2016
• Device Model Number: N140
• Device Catalogue Number: N140
• Device Lot Number: 113338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/10/2024
• Date Device Manufactured: 02/04/2014
• 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; Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female