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)

Patient Problems Bradycardia (1751); Head Injury (1879); Syncope/Fainting (4411); Limb Fracture (4518)

Event Date 06/21/2021

Event Type  Injury  

Manufacturer Narrative

Our records indicate this implantable device will not be returned.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had entered safety mode.The patient presented to the emergency room (er) with syncope; he had hit his head and might have gotten an ankle fracture.The patient was hospitalized.Additional information received indicated that the battery of this crt-p had depleted prematurely.In addition, there was oversensing and pacing inhibition with greater than 2 seconds of asystole noted.The crt-p was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Our records indicate this implantable device will not be returned.If information is provided in the future, a supplemental report will be issued.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 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) had entered safety mode.The patient presented to the emergency room (er) with syncope; he had hit his head and might have gotten an ankle fracture.The patient was hospitalized.Additional information received indicated that the battery of this crt-p had depleted prematurely.In addition, there was oversensing and pacing inhibition with greater than 2 seconds of asystole noted.The crt-p was explanted and replaced.No additional adverse patient effects were reported.Additional information received reported that this crt-p was returned for analysis.

• 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: 12221505
• MDR Text Key: 263362084
• Report Number: 2124215-2021-20206
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 06/25/2022

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: 10/10/2015
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 104598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: 06/23/2022
• Supplement Dates FDA Received: 06/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Sex: Male