MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTIO; PACEMAKER

Model Number K064

Device Problems Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Battery Problem (2885)

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

Event Date 08/01/2021

Event Type  Injury  

Event Description

It was reported that there were concerns regarding premature battery depletion of this pacemaker.A request was made to have data from this device analyzed and the analysis confirmed that there were no signs of premature battery depletion and no abnormal faults or resets.The increase in power consumption is due to increases in the thresholds as well as the lower impedances.Additional information received indicates that this pacemaker exhibited premature battery depletion and was found to be in safety mode.Subsequently, a revision procedure was performed and the pacemaker was explanted and replaced.No additional adverse patient effects were reported.

Event Description

It was reported that there were concerns regarding premature battery depletion of this pacemaker.A request was made to have data from this device analyzed and the analysis confirmed that there were no signs of premature battery depletion and no abnormal faults or resets.The increase in power consumption is due to increases in the thresholds as well as the lower impedances.Additional information received indicates that this pacemaker exhibited premature battery depletion and was found to be in safety mode.Subsequently, 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/determined it had undergone resets and that bradycardia therapy remained available.The system resets occurred during a telemetry session while communicating with the latitude remote monitoring system causing 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 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.

• 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: 18838348
• MDR Text Key: 336911447
• Report Number: 2124215-2024-13418
• 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: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 05/07/2024

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: 10/16/2016
• Device Model Number: K064
• Device Catalogue Number: K064
• Device Lot Number: 389796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2014
• 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
• Patient Age: 65 YR
• Patient Sex: Male