MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTUA; IMPLANTABLE DEVICE

Model Number V273

Device Problems Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Syncope/Fainting (4411); Asystole (4442)

Event Date 10/06/2022

Event Type  Injury  

Event Description

It was reported that the physician requested for a device check as this patient with a cardiac resynchronization therapy pacemaker (crt-p) exhibited syncopal episodes.This resulted in the patient experiencing asystole.Upon further investigation, it was found that this device is in safety mode.The patient was hospitalized overnight.The next day, the patient underwent a generator replacement, and the device was explanted and replaced successfully.The device is expected to be returned.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.

Event Description

It was reported that the physician requested for a device check as this patient with a cardiac resynchronization therapy pacemaker (crt-p) exhibited syncopal episodes.This resulted in the patient experiencing asystole.Upon further investigation, it was found that this device is in safety mode.The patient was hospitalized overnight.The next day, the patient underwent a generator replacement, and the device was explanted and replaced successfully.The device is expected to be returned.No additional adverse patient effects were reported.

• Brand Name: INTUA
• Type of Device: IMPLANTABLE DEVICE
• 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: 15591118
• MDR Text Key: 301626571
• Report Number: 2124215-2022-41140
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536670
• UDI-Public: 00802526536670
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/08/2016
• Device Model Number: V273
• Device Catalogue Number: V273
• Device Lot Number: 101097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2014
• 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): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male