MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESSENTIO EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number L121

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Device (2588); Inappropriate or Unexpected Reset (2959)

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

Event Date 04/09/2023

Event Type  Injury  

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that this pacemaker was explanted and replaced due to entering safety mode.No additional adverse patient effects were reported, and this pacemaker was returned for analysis.

Event Description

It was reported that this pacemaker was explanted and replaced due to entering safety mode.No additional adverse patient effects were reported, and this pacemaker was returned for analysis.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.It was confirmed the device was operating in safety mode.A battery issue was suspected and the device case was opened to facilitate inspection and testing of the internal components.The battery voltage was confirmed to be lower than expected.The battery was removed and replaced with an external power source.The current drain was measured and found to be normal during that testing.The battery was forwarded for detailed analysis.Despite this analysis, the root cause of the battery issue could not be confirmed.During analysis of this device, evidence of an issue with the low voltage capacitors was also identified.It was determined that the capacitors were compromised due to the presence of excess hydrogen in the device case.This finding contributed to the observed premature battery depletion.Boston scientific issued a field safety notice regarding a subset of devices in the accolade pacemaker family that have a potential of exhibiting this behavior.This particular device is included in the hydrogen induced premature depletion advisory population.

• Brand Name: ESSENTIO EL DR
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 16792442
• MDR Text Key: 313799626
• Report Number: 2124215-2023-19338
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

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: 10/05/2017
• Device Model Number: L121
• Device Catalogue Number: L121
• Device Lot Number: 705881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2023
• Initial Date FDA Received: 04/21/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2015
• 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: 77 YR
• Patient Sex: Male