MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTIO; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number J063

Device Problem Premature Discharge of Battery (1057)

Patient Problems Anxiety (2328); Malaise (2359)

Event Date 11/19/2021

Event Type  Injury  

Event Description

It was reported that the battery of this implantable device was suspected to be depleting prematurely.Explant status was triggered on november 16, 2021.The patient felt unwell and experienced some anxiety related to the event.The device was subsequently replaced with a non-boston scientific product and no additional adverse patient effects were reported.The device was returned for analysis.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.A longevity calculation was completed and it was confirmed that the device did meet longevity expectations.Device memory was reviewed and it was confirmed that the device was previously in ddd mode while implanted, with prolonged high atrial rates.Lifetime sense and pace count data noted high atrial sensing.The device was then exposed to simulated heart load conditions, and the pacing and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.Chronic high atrial rates, as occurred with this device, can reduce longevity in devices that are programmed ddd(r) 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 was determined to be the cause of the longevity being lower than expected.

Event Description

It was reported that the battery of this implantable device was suspected to be depleting prematurely.Explant status was triggered on (b)(6) 2021.The patient felt unwell and experienced some anxiety related to the event.The device was subsequently replaced with a non-boston scientific product and no additional adverse patient effects were reported.The device was returned for analysis.

• Brand Name: ADVANTIO
• 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 degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 13444951
• MDR Text Key: 285042879
• Report Number: 2124215-2021-40865
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/24/2016
• Device Model Number: J063
• Device Catalogue Number: J063
• Device Lot Number: 157963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2014
• 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
• Patient Outcome(s): Required Intervention; Hospitalization