MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTIO; PACEMAKER

Model Number K064

Device Problems Over-Sensing (1438); Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Device (2588)

Patient Problem Syncope/Fainting (4411)

Event Date 11/05/2022

Event Type  Injury  

Event Description

It was reported that this patient experienced a syncopal event.Upon review, the pacemaker was found to be in safety mode.Additionally, it was noted to have myopotential oversensing.Subsequently, the patient was hospitalized with a temporary wire.Then, a revision procedure was performed and the pacemaker was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode due to system resets.It was confirmed that brady therapy remained available.The system resets occurred during a telemetry session and caused the device to enter safety mode.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance resulted in the system resets due to temporary high-power consumption related to telemetry attempts and subsequent reversion to safety mode operation.Boston scientific has issued a field safety notice regarding ingenio extended life (el) and cardiac resynchronization therapy pacemaker (crt-p) devices that may exhibit this behavior.This particular device is included in the high impedance in ingenio extended life (el) pacemaker and crt-p advisory population.Correction to field b3: date of event.

Event Description

It was reported that this patient experienced a syncopal event.Upon review, the pacemaker was found to be in safety mode.Additionally, it was noted myopotential oversensing.Subsequently, the patient was hospitalized with a temporary wire.Then, a revision procedure was performed and the pacemaker was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: ADVANTIO
• Type of Device: PACEMAKER
• 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: 15950821
• MDR Text Key: 305172151
• Report Number: 2124215-2022-51771
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526516719
• UDI-Public: 00802526516719
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970003/S132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/10/2014
• Device Model Number: K064
• Device Catalogue Number: K064
• Device Lot Number: 111916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2012
• 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): Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male