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

Model Number V173

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Interrogation Problem (4017)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 08/17/2022

Event Type  Injury  

Event Description

It was reported that just prior to a scheduled device replacement procedure, this cardiac resynchronization therapy pacemaker (crt-p) device was interrogated and found to be in safety mode with limited critical therapy available.The device was noted to have reached explant indicator approximately one month before.The boston scientific field representative stated they think the pre-surgery interrogation caused the device to revert to safety mode.It was also noted that the left ventricular (lv) lead had been previously programmed off due to the patient experiencing unwanted stimulation, but the lv lead came back on when the device reverted to safety mode.The device and lv lead were 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 on the day of the device replacement procedure 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 just prior to a scheduled device replacement procedure, this cardiac resynchronization therapy pacemaker (crt-p) device was interrogated and found to be in safety mode with limited critical therapy available.The device was noted to have reached explant indicator approximately one month before.The boston scientific field representative stated they think the pre-surgery interrogation caused the device to revert to safety mode.It was also noted that the left ventricular (lv) lead had been previously programmed off due to the patient experiencing unwanted stimulation, but the lv lead came back on when the device reverted to safety mode.The device and lv lead were explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: INVIVE
• 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: 15271650
• MDR Text Key: 298384942
• Report Number: 2124215-2022-31943
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

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: 08/07/2015
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 104227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 08/22/2022
• Supplement Dates Manufacturer Received: 02/14/2023
• Supplement Dates FDA Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2018-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female