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

Model Number L231

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

Patient Problem Anxiety (2328)

Event Date 01/12/2021

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 five years between one year follow ups.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.Patient is being remotely monitored at the moment and experienced anxiety as a result of the event, no medication needed.Physician expressed a concern regarding the battery behavior of proponent devices.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.Remaining longevity decreased five years between one year follow ups.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.Patient experienced anxiety as a result of the event, no medication needed.Physician expressed a concern regarding the battery behavior of proponent devices.This device was replaced and returned for analysis.No additional adverse patient effects were reported.Customer comments: physician requests a possibility to have battery details printed from the programmer, a shortcut on latitude to view battery details and to have an alert when high/abnormal energy drain is detected.

Manufacturer Narrative

Initial: additional information was requested.The investigation will be updated should further information be provided.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 (b)(6) 2018, which was expanded in (b)(6) 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.

• Brand Name: PROPONENT 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
• MDR Report Key: 11735693
• MDR Text Key: 247706094
• Report Number: 2124215-2021-10592
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

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: 11/20/2017
• Device Model Number: L231
• Device Catalogue Number: L231
• Device Lot Number: 710625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 04/27/2021
• Supplement Dates Manufacturer Received: 05/27/2021
• Supplement Dates FDA Received: 07/14/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention