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

Model Number W173

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 11/15/2022

Event Type  Injury  

Event Description

It was reported that the patient with this pacemaker presented to the emergency room (er) due to phrenic nerve stimulation.Upon interrogation, the device was found to have reverted to safety mode.Subsequently, the patient underwent a revision procedure, and this device was explanted and replaced without incident.Besides intervention, there were no other adverse patient effects reported.Device return is expected.

Manufacturer Narrative

To date, this device has not been returned; therefore, technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient with this pacemaker presented to the emergency room (er) due to phrenic nerve stimulation.Upon interrogation, the device was found to have reverted to safety mode.Subsequently, the patient underwent a revision procedure, and this device was explanted and replaced without incident.Besides intervention, there were no other adverse patient effects reported.This device has not been returned despite good faith efforts thus far.Should the device be returned in the future, laboratory analysis will be performed, and an updated report will be issued.

• 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: 15807919
• MDR Text Key: 303759013
• Report Number: 2124215-2022-47492
• 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: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/29/2015
• Device Model Number: W173
• Device Catalogue Number: W173
• Device Lot Number: 113960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• 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