MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number V173

Device Problems Premature Discharge of Battery (1057); Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959)

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

Event Date 01/25/2022

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) experienced fainting and was admitted to the hospital, due to the crt-p 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 ten months remained.Technical services (ts) discussed the limited device functionality, and recommended emergent replacement, as there is no reprogramming available in safety mode.The patient was pace dependent and utilized an external pacemaker until procedure.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 device 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.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.Analysis identified, device characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported, that the patient with this cardiac resynchronization therapy pacemaker (crt-p) experienced fainting.And was admitted to the hospital, due to the crt-p 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 ten months remained.Technical services (ts) discussed the limited device functionality, and recommended, emergent replacement, as there is no reprogramming available in safety mode.The patient was pace dependent and utilized an external pacemaker until procedure.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 device 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 the patient with this cardiac resynchronization therapy pacemaker (crt-p) experienced fainting and was admitted to the hospital, due to the crt-p 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 ten months remained.Technical services (ts) discussed the limited device functionality, and recommended emergent replacement, as there is no reprogramming available in safety mode.The patient was pace dependent and utilized an external pacemaker until procedure.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 device 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.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.Analysis identified device characteristics that would have caused or contributed to the reported clinical observations.

• Brand Name: INVIVE
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• 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: 14048568
• MDR Text Key: 288865185
• Report Number: 2124215-2022-07307
• 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: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/02/2015
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 103276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female