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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2021

Event Type  malfunction  

Event Description

It was reported that the battery of this pacemaker was suspected to be depleting prematurely, as the power consumption was higher than expected.A request was made to have data from this device analyzed.Data analysis showed the battery consumption had been increasing at an unexpected rate, and a technical services (ts) consultant recommended device replacement.At this time, there is no evidence to suggest that intervention has been performed.No adverse patient effects were reported.

Manufacturer Narrative

This device remains implanted; therefore, technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the battery of this pacemaker was suspected to be depleting prematurely, as the power consumption was higher than expected.A request was made to have data from this device analyzed.Data analysis showed the battery consumption had been increasing at an unexpected rate, and a technical services (ts) consultant recommended device replacement.At this time, there is no evidence to suggest that intervention has been performed.No adverse patient effects were reported.Additional information received confirmed this patient is being closely monitored via the latitude remote patient monitoring system in order to postpone the replacement procedure as long as possible.

• 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: 13138710
• MDR Text Key: 283763594
• Report Number: 2124215-2021-38523
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/19/2017
• Device Model Number: L231
• Device Catalogue Number: L231
• Device Lot Number: 708768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2015
• 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