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); Human-Device Interface Problem (2949)

Patient Problem Anxiety (2328)

Event Date 06/09/2021

Event Type  malfunction  

Event Description

It was reported that during a routine follow up appointment, the battery energy usage for this pacemaker was noted to have increased to 115 percent.Due to concern over possible premature battery depletion, review of the device's data by engineering was requested.It was also noted that the patient was experiencing anxiety symptoms due to the possibility of having to undergo an early device changeout procedure.The patient was not placed on any medication due to the anxiety.Engineering review of the device data confirmed the increase in battery usage had slowly developed over time and it was discussed there was no urgent need to replace this pacemaker at this time.Continued monitoring at the discretion of the patient's physician was recommended.Currently, 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: 12139532
• MDR Text Key: 260682052
• Report Number: 2124215-2021-18405
• 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: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/28/2017
• Device Model Number: L231
• Device Catalogue Number: L231
• Device Lot Number: 701208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1