MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENERGEN ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

Model Number E141

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885)

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

Event Date 02/26/2024

Event Type  Injury  

Event Description

It was reported that this implantable cardioverter defibrillator (icd) exhibited longevity calculation from 3.5 years, went down to elective replacement indicator (eri).Data was submitted for analysis and analysis confirmed that there were no low voltage fault triggered however, the power consumption is increasing in a gradual fashion.A device replacement was recommended.The 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 device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) exhibited longevity calculation from 3.5 years, went down to elective replacement indicator (eri).Data was submitted for analysis and analysis confirmed that there were no low voltage fault triggered however, the power consumption is increasing in a gradual fashion.A device replacement was recommended.The device remains in service.No adverse patient effects were reported.Additional information was received indicating that the device was explanted.No additional adverse patient effects were reported.

• Brand Name: ENERGEN ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
• 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: 19149123
• MDR Text Key: 340646355
• Report Number: 2124215-2024-24063
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526480720
• UDI-Public: 00802526480720
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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: 12/16/2012
• Device Model Number: E141
• Device Catalogue Number: E141
• Device Lot Number: 102251
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2011
• 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: 72 YR
• Patient Sex: Female