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

Model Number L210

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

Patient Problem Anxiety (2328)

Event Date 02/25/2021

Event Type  Injury  

Manufacturer Narrative

Additional information was requested.The investigation will be updated should further information be provided.

Event Description

It was reported that the battery of this implantable device was suspected to be depleting prematurely.Remaining longevity decreased two and half years between six month follow-ups, power consumption of 128%.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.Plan is to remotely monitor every three months in order to postpone the surgical procedure as long as possible.Patient experienced anxiety as a result, no medication needed.This device remains in service.No adverse patient effects were reported.

Event Description

It was reported that the battery of this implantable device was suspected to be depleting prematurely during a routine follow up.The estimated longevity decreased two and half years within a six month period.The power consumption was higher than expected.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.The plan was to remotely monitor every three months in order to postpone the surgical procedure as long as possible.The patient experienced anxiety as a result, no medication needed.This device was replaced and returned for analysis.No additional adverse patient effects were reported.

Manufacturer Narrative

Supplemental: 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 in september 2018, which was expanded in june 2021, regarding a subset of devices in the accolade pacemaker family that has an elevated potential of exhibiting this behavior.This particular device is included in the hydrogen induced premature depletion advisory population.Initial: additional information was requested.The investigation will be updated should further information be provided.

• Brand Name: PROPONENT 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: 11704703
• MDR Text Key: 246674868
• Report Number: 2124215-2021-09457
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/14/2019
• Device Model Number: L210
• Device Catalogue Number: L210
• Device Lot Number: 752031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization