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

Model Number	N140
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the battery of this cardiac resynchronization therapy defibrillator (crt-d) reached end-of-life (eol) status, but generator change could not be done a week or so for other circumstances.The patient is dependent and got a left ventricular assist device (lvad) and suddenly developed a focal premature ventricular contractions which would set off into a terrible course of ventricular tachycardia (vt)/ventricular fibrillation (vf) and got shock many times that caused the battery to deplete.The patient was on medication but could not do anything about it.Additionally, the patient's rate has dropped from 80 to 50.Boston scientific technical services (ts) stated that with a battery status of eol at this point, we can no longer guarantee pacing therapy.To date, this device remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.Upon receipt at our post market quality assurance laboratory, the device was forwarded to detailed analysis for further investigation.The memory log was reviewed and found that while implanted the device recorded no code 1003.No other suspicious faults or resets were noted.The device diagnostic data spreadsheet graph shows a cell depletion pattern that is consistent with normal battery depletion.
Event or Problem Description
It was reported that the battery of this cardiac resynchronization therapy defibrillator (crt-d) reached end-of-life (eol) status, but generator change could not be done a week or so for other circumstances.The patient is dependent and got a left ventricular assist device (lvad) and suddenly developed a focal premature ventricular contractions which would set off into a terrible course of ventricular tachycardia (vt)/ventricular fibrillation (vf) and got shock many times that caused the battery to deplete.The patient was on medication but could not do anything about it.Additionally, the patient's rate has dropped from 80 to 50.Boston scientific technical services (ts) stated that with a battery status of eol at this point, we can no longer guarantee pacing therapy.Subsequently, this device was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: ENERGEN CRT-D
• Common Device Name: IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18354255
• Report Number: 2124215-2023-72044
• Device Sequence Number: 6923836
• Product Code: LWP
• UDI-Device Identifier: 00802526480959
• UDI-Public: 00802526480959
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2024

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: 09/27/2015
• Device Model Number: N140
• Device Catalogue Number: N140
• Device Lot Number: 111745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2013
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male