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

Model Number V173

Device Problems Signal Artifact/Noise (1036); Premature Discharge of Battery (1057); Over-Sensing (1438); Pacing Problem (1439); Pocket Stimulation (1463); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959)

Patient Problem Asystole (4442)

Event Date 03/01/2022

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) during routine follow up, exhibited an alert that the device entered safety mode unexpectedly.It was noted the device was suspected to have exhibited premature battery depletion as prior review indicated two years remained.Technical services (ts) discussed the limited device functionality, and recommended emergent replacement, as there is no reprogramming available in safety mode.Subsequently the next day, the crt-p was explanted and a new device of a different model, was successfully implanted.No additional adverse patient effects were reported.The crt-p has been returned and analysis is pending.This report will be updated with pertinent information, upon completion of product analysis.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) during routine follow up, exhibited an alert that the device entered safety mode unexpectedly.It was noted the device was suspected to have exhibited premature battery depletion as prior review indicated two years remained.Technical services (ts) discussed the limited device functionality, and recommended emergent replacement, as there is no reprogramming available in safety mode.Subsequently the next day, the crt-p was explanted and a new device of a different model, was successfully implanted.No additional adverse patient effects were reported.The crt-p has been returned and analysis is pending.This report will be updated with pertinent information, upon completion of product 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 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.

• 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: 14068422
• MDR Text Key: 288994898
• Report Number: 2124215-2022-07647
• 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
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/13/2015
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 104247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2013
• 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: 81 YR
• Patient Sex: Male