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

Model Number	N141
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Low impedance (2285); Delayed Charge Time (2586); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there were concerns about this cardiac resynchronization therapy defibrillator (crt-d)'s battery longevity.Technical services (ts) reviewed the reports and noted that there was a delay in charge times that resulted in the device reaching explant.Additionally, the device exhibited jumpy low out of range pacing impedance on the right atrial (ra) lead channel and had atrial tachy response (atr) episodes due to oversensing of noisy signals.The device remains in use.No adverse patient effects were reported.
Event or Problem Description
It was reported that there were concerns about this cardiac resynchronization therapy defibrillator (crt-d)'s battery longevity.Technical services (ts) reviewed the reports and noted that there was a delay in charge times that resulted in the device reaching explant.Additionally, the device exhibited jumpy low out of range pacing impedance on the right atrial (ra) lead channel and had atrial tachy response (atr) episodes due to oversensing of noisy signals.The device remains in use.No adverse patient effects were reported.Additional information received indicates that the device was explanted and replaced.No additional adverse patient effects were reported.The device was returned for analysis.
Additional Manufacturer Narrative
This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.The associated investigation determined that this device exhibited intermittent fluctuations in impedance measurements with no conclusive evidence of a product performance issue; please refer to the description for more information regarding the specific circumstances of this event.
Event or Problem Description
It was reported that there were concerns about this cardiac resynchronization therapy defibrillator (crt-d)'s battery longevity.Technical services (ts) reviewed the reports and noted that there was a delay in charge times that resulted in the device reaching explant.Additionally, the device exhibited jumpy low out of range pacing impedance on the right atrial (ra) lead channel and had atrial tachy response (atr) episodes due to oversensing of noisy signals.The device remains in use.No adverse patient effects were reported.Additional information received indicates that the device was explanted and replaced.No additional adverse patient effects were reported.The device was returned for analysis.

• 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: 19314217
• Report Number: 2124215-2024-29340
• Device Sequence Number: 16910009
• Product Code: LWP
• UDI-Device Identifier: 00802526480966
• UDI-Public: 00802526480966
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2024

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: 11/21/2015
• Device Model Number: N141
• Device Catalogue Number: N141
• Device Lot Number: 112226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 06/05/2024; 11/08/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/11/2024; 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2013
• 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: 75 YR
• Patient Sex: Male