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 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited sensing of chronic high atrial rates which may impact battery longevity over time.Please refer to the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that the pacemaker's battery longevity decreased from 12 years remaining to 7 years remaining in three months.The pacemaker was reprogrammed to pace and sense in the ventricle only due to high atrial fibrillation burden.It was noted the patient exhibited signs of anxiety due to concern over battery depletion and possible device change out procedure in the future.It was noted that no medication was prescribed to the patient and the patient's anxiety was expected to recover.The physician was concerned over possible premature battery depletion from causes other than af and requested the data from the device be reviewed by technical services and engineering.The physician also suggested improvements such as having the battery details printed from the programmer, a shortcut on the remote home monitoring website to view battery details and an alert when high abnormal energy drain is detected.Engineering analysis determined the device is high rate atrial sensing at an average rate of 216 beats per minute.The pacemaker also had a signal artifact monitoring software patch installed and enabled.High rate atrial sensing can cause an increase in power consumption and the software patch can also consume additional power in the presence of high rate atrial sensing.Reprogramming options to reduce high rate atrial sensing were discussed.The pacemaker remains in service and no adverse patient effects were reported.

• 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
• 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: 12114293
• MDR Text Key: 260258362
• Report Number: 2124215-2021-17754
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/20/2018
• Device Model Number: L231
• Device Catalogue Number: L231
• Device Lot Number: 717485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1