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

Model Number K084

Device Problems Failure to Capture (1081); Pocket Stimulation (1463); Inappropriate or Unexpected Reset (2959)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 01/03/2024

Event Type  Injury  

Event Description

It was reported that this pacemaker reverted to safety mode.Subsequently, evidence of loss of capture (loc) was noted on some electrograms (egms) and the patient reported intermittent pectoral stimulation.Additional information was received from the company representative that no evidence of loc was observed by the company representative, however, was reported by a health care professional (hcp).It was suspected that the function of the device in safety mode with unipolar sensing may have resulted in the reported observations.Surgical intervention was undertaken.The device was explanted and replaced.No additional adverse patient effects were reported.All lead data at the time of device replacement was satisfactory with no change in threshold measurements.The product is expected to be returned for analysis.This report will be updated upon return and completion of 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 ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18531161
• MDR Text Key: 333088134
• Report Number: 2124215-2024-02286
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2024

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: 10/04/2014
• Device Model Number: K084
• Device Catalogue Number: K084
• Device Lot Number: 111417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2012
• 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): Hospitalization; Required Intervention