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

Model Number L331

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885); High Capture Threshold (3266)

Patient Problem Atrial Fibrillation (1729)

Event Date 10/01/2021

Event Type  malfunction  

Event Description

It was reported during a routine office visit, that this pacemaker device was suspected of behaving in a manner consistent with a premature battery depletion (pbd).A technical service (ts) consultant reviewed data with the physician, noting that the device battery longevity had eight years remaining in november 2020, and now the battery longevity is six months remaining.Ts discussed that the patient is in chronic atrial fibrillation since october 2021, (100% of every day).Thresholds have been increasing from 1.1v to 1.6v.Ts provided recommendations for programming to help extend battery longevity.Ts confirmed this device does not have a premature battery depletion.The physician will recheck the patient in 3 months.The device remains implanted.No adverse patient effects were reported.

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.Chronic high atrial sensing rates, such as for patients with chronic atrial fibrillation, can reduce longevity in devices that are programmed with atrial sensing on.Device power consumption increases proportional to the additional processing for sensed atrial events.As a result, the high rate of atrial sensing can result in the longevity being lower than expected, as observed with this device.

• Brand Name: ACCOLADE 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: 13912439
• MDR Text Key: 288054270
• Report Number: 2124215-2022-06225
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/06/2022
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 882927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female