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

Model Number W275

Device Problems Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Fall (1848)

Event Date 10/08/2022

Event Type  Injury  

Event Description

It was reported that this device was operating in safety mode.The patient is elderly and recently fell while getting dressed possibly due to myopotential oversensing secondary to unipolar configuration in safety mode.The patient was hospitalized, and the device was replaced.The explanted device is expected to be returned for evaluation however as of today has not been received.No additional adverse patient effects were reported.

Manufacturer Narrative

This device not been returned.As such, physical analysis has not been conducted in our laboratory.As no further information concerning this report is expected our investigation is complete.This investigation will be updated should further information be provided.

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.

Event Description

It was reported that this device was operating in safety mode.The patient is elderly and recently fell while getting dressed, possibly due to myopotential oversensing, secondary to unipolar configuration in safety mode.The patient was hospitalized, and the device was replaced.The device was returned, and analysis completed.

• 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: 15640105
• MDR Text Key: 302091700
• Report Number: 2124215-2022-42651
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/28/2023

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: 06/30/2016
• Device Model Number: W275
• Device Catalogue Number: W275
• Device Lot Number: 113152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2022
• Initial Date FDA Received: 10/20/2022
• Supplement Dates Manufacturer Received: 08/22/2023
• Supplement Dates FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization