MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

Model Number V173

Device Problems Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Dizziness (2194); Syncope/Fainting (4411); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/21/2022

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode during a routine check.It was recommended that this device be replaced.No adverse patient effects were reported.The device remains in service and there is no evidence to suggest a device replacement procedure has been scheduled at this time.

Manufacturer Narrative

Corrected fields: e section (initial reporter) with physician information.(b)(6).

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode during a routine check.It was recommended that this device be replaced.No adverse patient effects were reported.The device remains in service and there is no evidence to suggest a device replacement procedure has been scheduled at this time.Additional information was received that this patient presented to urgent care due to experiencing symptoms of dizziness and syncope.Upon review of the patients most recent home monitoring reports, it was advised that the patient go to the hospital and undergo a generator change out procedure immediately as they are dependent.Subsequently, the patient went to the hospital where they were admitted.Once the device was interrogated, it was found due to unipolar programming while the device was in safety mode, oversensing and pacing inhibition were observed.Ultimately, the device was explanted and successfully replace.No additional adverse patient effects were reported.This device is expected to be returned for analysis.

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/or while communicating with the latitude remote monitoring system 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.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode during a routine check.It was recommended that this device be replaced.No adverse patient effects were reported.The device remains in service and there is no evidence to suggest a device replacement procedure has been scheduled at this time.Additional information was received that this patient presented to urgent care due to experiencing symptoms of dizziness and syncope.Upon review of the patients most recent home monitoring reports, it was advised that the patient go to the hospital and undergo a generator change out procedure immediately as they are dependent.Subsequently, the patient went to the hospital where they were admitted.Once the device was interrogated, it was found due to unipolar programming while the device was in safety mode, oversensing and pacing inhibition were observed.Ultimately, the device was explanted and successfully replace.No additional adverse patient effects were reported.This device is expected to be returned for analysis.

• Brand Name: INVIVE
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY 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: 15304030
• MDR Text Key: 302259840
• Report Number: 2124215-2022-32700
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536632
• UDI-Public: 00802526536632
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/11/2016
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 106635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2014
• 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: 79 YR
• Patient Sex: Male