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

Model Number K087

Device Problems Premature Discharge of Battery (1057); Inappropriate or Unexpected Reset (2959)

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

Event Date 02/27/2023

Event Type  malfunction  

Event Description

It was reported that during a routine in-clinic follow-up, this pacemaker was found to have reverted to safety mode.The patient was noted to be asymptomatic to unipolar pacing in vvi.The device battery was suspected to be depleting prematurely.The patient was going to undergo device explant and replacement with a non-boston scientific device on an unknown future date.No further information was known or provided since the replacement device will be non-boston scientific.The return of the device is not expected.No adverse patient effects were reported.Available information indicates this device remains in service.If information is provided in the future, a supplemental report will be issued.

• 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: 16460760
• MDR Text Key: 310437291
• Report Number: 2124215-2023-09575
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 03/01/2023

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: 01/10/2015
• Device Model Number: K087
• Device Catalogue Number: K087
• Device Lot Number: 111128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2013
• 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