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

Model Number L331

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885); Human-Device Interface Problem (2949)

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

Event Date 10/28/2021

Event Type  Injury  

Event Description

It was reported that the battery of this implantable device was suspected to be depleting prematurely.The estimated longevity decreased four years within a nine month period with no evident changes in parameter settings and pacing percentage.An emergent follow up was performed to save the device's data.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended and is already scheduled.The physician mentioned that an algorithm should be incorporated into the software that spontaneously detects and alerts the accelerated battery degradation.This device remains in service.No adverse patient effects were reported.The complaint device still remains in service; therefore, no product analysis could be performed.The complaint investigation conclusion code is cause not established.

Manufacturer Narrative

At this time, no further information is available.Should additional information become available this report will be updated.

Event Description

It was reported that the battery of this implantable device was suspected to be depleting prematurely.The estimated longevity decreased four years within a nine month period with no evident changes in parameter settings and pacing percentage.An emergent follow up was performed to save the device's data.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended and is already scheduled.The physician mentioned that an algorithm should be incorporated into the software that spontaneously detects and alerts the accelerated battery degradation.This device remains in service.No adverse patient effects were reported.Additional information provided indicates the device was explanted and replaced.Reportedly, the device recorded a signal artifact monitor (sam) episode, however, there are no details regarding the cause of the episode.No additional adverse patient effects were reported.The device is expected to be returned for analysis.

Event Description

It was reported that the battery of this implantable device was suspected to be depleting prematurely.The estimated longevity decreased four years within a nine month period with no evident changes in parameter settings and pacing percentage.An emergent follow up was performed to save the device data.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended and is already scheduled.The physician mentioned that an algorithm should be incorporated into the software that spontaneously detects and alerts the accelerated battery degradation.This device remains in service.No adverse patient effects were reported.Additional information provided indicates the device was explanted and replaced.Reportedly, the device recorded a signal artifact monitor (sam) episode, however, there are no details regarding the cause of the episode.No additional adverse patient effects were reported.The device is expected to be returned for analysis.The device was returned for 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.

• Brand Name: ACCOLADE MRI 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; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 13444704
• MDR Text Key: 285223568
• Report Number: 2124215-2021-40870
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559266
• UDI-Public: 00802526559266
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/04/2017
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 705328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female