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

Model Number J063

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

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

Event Date 03/22/2024

Event Type  malfunction  

Event Description

It was reported that in between follow-up appointments, an unexpected decrease in longevity was noted from this implantable pacemaker.It was hypothesized that the battery was depleting prematurely, but incorrect device information was forwarded to boston scientific technical services for review.At this time, this pacemaker remains implanted and in-service.No adverse patient effects were reported.Information has been requested regarding the healthcare facility and physician details, but a response has not yet been received.

Event Description

It was reported that in between follow-up appointments, an unexpected decrease in longevity was noted from this implantable pacemaker.It was hypothesized that the battery was depleting prematurely, but incorrect device information was forwarded to boston scientific technical services for review.However, it was later clarified that the physician did not allege that the device was depleting prematurely.At this time, this pacemaker remains implanted and in-service.No adverse patient effects were reported.

• 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: 19053208
• MDR Text Key: 339878247
• Report Number: 2124215-2024-20837
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/07/2017
• Device Model Number: J063
• Device Catalogue Number: J063
• Device Lot Number: 252766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1