MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESSENTIO EL DR; IMPLANTABLE PACEMAKER

Model Number L121

Device Problem Battery Problem (2885)

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

Event Date 03/26/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this implantable pacemaker exhibited longevity calculations from 4 years remaining to 1.5 years remaining.Data was sent for engineering analysis.Analysis showed that the power consumption is increasing in a gradual fashion.Device replacement was suggested.This device remains in service.No adverse patient effects were reported.

Event Description

It was reported that this implantable pacemaker exhibited longevity calculations from 4 years remaining to 1.5 years remaining.Data was sent for engineering analysis.Analysis showed that the power consumption is increasing in a gradual fashion.Device replacement was suggested.Additional information received indicates that the device was explanted and will be returned for analysis.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.The return of the was requested.If the product is returned, product investigation will be performed, and - complaint would be updated upon analysis completion.

• Brand Name: ESSENTIO EL DR
• Type of Device: IMPLANTABLE PACEMAKER
• 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: 19094448
• MDR Text Key: 340458956
• Report Number: 2124215-2024-22276
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526558986
• UDI-Public: 00802526558986
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970003/S167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2024

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: 06/05/2017
• Device Model Number: L121
• Device Catalogue Number: L121
• Device Lot Number: 702243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2015
• 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): Required Intervention; Hospitalization
• Patient Age: 89 YR
• Patient Sex: Female