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

Model Number L111

Device Problems Defective Device (2588); Patient-Device Incompatibility (2682)

Patient Problem Burning Sensation (2146)

Event Date 10/12/2018

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that this patient with pacemaker stated that device was burning and kept patient up at night.Boston scientific technical services (ts) recommended patient to see the physician about burning.This pacemaker device remains in service.No adverse patient effects were reported.

Manufacturer Narrative

The complainant indicated that the device was not returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental report will be filed.

Event Description

This supplemental report is being filed as update from product investigation was received.Boston scientific received information that this patient with pacemaker stated that device was burning and kept patient up at night.Boston scientific technical services (ts) recommended patient to see the physician about burning.This pacemaker device remains in service.No adverse patient effects were reported.

Manufacturer Narrative

The complainant indicated that the device was not returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental report will be filed.The product has been received for analysis.Upon completion of the failure analysis of the complaint product, if there is any further relevant information from that review, a supplemental report will be filed.

Event Description

Additional information received indicates that the device was explanted.No additional adverse patient effects were reported.

Manufacturer Narrative

The complainant indicated that the device was not returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental report will be filed.The product has been received for analysis.Upon completion of the failure analysis of the complaint product, if there is any further relevant information from that review, a supplemental report will be filed.Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.A high current drain was detected, but the battery still supported full device function.Detailed analysis confirmed the identified high current drain was a result of compromised capacitors.This resulted in the observed premature battery depletion.It was determined that the capacitors were compromised due to the presence of excess hydrogen in the device case.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.

Event Description

Additional information received indicates that the device was explanted.No additional adverse patient effects were reported.

• Brand Name: ESSENTIO MRI 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; cashel road; ,; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8300004
• MDR Text Key: 134860225
• Report Number: 2124215-2018-63804
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526558962
• UDI-Public: 00802526558962
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/14/2024

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: 10/25/2019
• Device Model Number: L111
• Device Catalogue Number: L111
• Device Lot Number: 324145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2018
• Initial Date FDA Received: 02/02/2019
• Supplement Dates Manufacturer Received: 02/06/2019; 04/03/2024; 06/27/2024
• Supplement Dates FDA Received: 05/10/2019; 04/09/2024; 07/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2017
• 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: 69 YR
• Patient Sex: Female