MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI SR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number L310

Device Problem Premature Discharge of Battery (1057)

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

Event Date 12/05/2022

Event Type  Injury  

Event Description

It was reported that the battery of this pacemaker was suspected to be prematurely depleting.Review of device data by boston scientific technical services confirmed the device is depleting abnormally and device replacement was recommended.The pacemaker remains in service and there have been no adverse patient effects were reported.This event will be updated should a revision procedure be performed and/or the pacemaker be returned back from the field for analysis.

Event Description

It was reported that the battery of this pacemaker was suspected to be prematurely depleting.Review of device data by boston scientific technical services confirmed the device is depleting abnormally and device replacement was recommended.The pacemaker remains in service and there have been no adverse patient effects were reported.Additional information provided from the field indicated surgical intervention was performed and the pacemaker was explanted and replaced.No additional adverse patient effects were reported.The pacemaker is expected to be returned back from the field for analysis, this event will be updated upon completion of analysis.

Manufacturer Narrative

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

It was reported that the battery of this pacemaker was suspected to be prematurely depleting.Review of device data by boston scientific technical services confirmed the device is depleting abnormally and device replacement was recommended.The pacemaker remains in service and there have been no adverse patient effects were reported.Additional information provided from the field indicated surgical intervention was performed and the pacemaker was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: ACCOLADE MRI SR
• 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; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16075062
• MDR Text Key: 308024415
• Report Number: 2124215-2022-55492
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559204
• UDI-Public: 00802526559204
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/14/2016
• Device Model Number: L310
• Device Catalogue Number: L310
• Device Lot Number: 101465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2014
• 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: 66 YR
• Patient Sex: Female