MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INLIVEN; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number W173

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

Patient Problems Loss of consciousness (2418); Syncope/Fainting (4411)

Event Date 06/13/2022

Event Type  Injury  

Manufacturer Narrative

This product has not been returned.As such, physical analysis has not been conducted in our laboratory.The conclusion of cause not established was selected because it can be concluded that unknown factors probably contributed to the event.This investigation will be updated should further information be provided.

Event Description

It was reported that an alert posted from the home monitor indicating that this cardiac resynchronization therapy pacemaker (crt-p) device is in safety mode.The patient reported a syncope episodes, felt dizzy and fainted.The patient was taken to the hospital emergency room, and admitted.A revision procedure was completed.A new device was implanted.Besides surgical intervention, no additional adverse patient effects were reported.The device will be returned for analysis.

Event Description

It was reported that an alert posted from the home monitor indicating that this cardiac resynchronization therapy pacemaker (crt-p) device is in safety mode.The patient reported a syncope episodes, felt dizzy and fainted.The patient was taken to the emergency room, and was admitted.The physician reported pacing inhibition when the patient moved his arm forward.A revision procedure was completed.A new device was implanted.Besides surgical intervention, 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 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: INLIVEN
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 14743639
• MDR Text Key: 294388915
• Report Number: 2124215-2022-22023
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/11/2015
• Device Model Number: W173
• Device Catalogue Number: W173
• Device Lot Number: 115877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male