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

Model Number J066

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2024

Event Type  Injury  

Event Description

It was reported that the pacemaker was suspected of exhibiting premature battery depletion.Approximately a year ago, the estimated battery longevity was showing 1.5 years remaining.However, today, the device had gone to backup mode of vvi at 50bpm.The plan is to replace this device soon.No adverse patient effects were reported.The device remains in-service.

Event Description

It was reported that the pacemaker was suspected of exhibiting premature battery depletion.Approximately a year ago, the estimated battery longevity was showing 1.5 years remaining.However, today, the device had gone to backup mode of vvi at 50bpm.The plan is to replace this device soon.No adverse patient effects were reported.The device remains in-service.Additional information was received, it was reported that the device was explanted and replaced.No additional adverse patient effects were reported.Despite our request, the explanted device was not retained.Therefore, the device is not available for returned.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Please refer to b5 describe event or problem for more information regarding the specific circumstances of this event.

Event Description

It was reported that the pacemaker was suspected of exhibiting premature battery depletion.Approximately a year ago, the estimated battery longevity was showing 1.5 years remaining.However, today, the device had gone to backup mode of vvi at 50bpm.The plan is to replace this device soon.No adverse patient effects were reported.The device remains in-service.Additional information was received, it was reported that the device was explanted and replaced.No additional adverse patient effects were reported.Despite our request, the explanted device was not retained.Therefore, the device is not available for returned.

• 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 ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19056966
• MDR Text Key: 339880448
• Report Number: 2124215-2024-21001
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/18/2016
• Device Model Number: J066
• Device Catalogue Number: J066
• Device Lot Number: 103745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/07/2024
• Supplement Dates Manufacturer Received: 04/17/2024; 04/23/2024
• Supplement Dates FDA Received: 04/23/2024; 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization