MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE; IMPLANTABLE PACEMAKER

Model Number W173

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959)

Patient Problem Malaise (2359)

Event Date 08/01/2023

Event Type  Injury  

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.

Event Description

It was reported that the patient implanted with this cardiac resynchronization therapy pacemaker (crt-p) was feeling unwell since august.Upon further evaluation, it was determined that the crt-p had entered safety mode.The patient was admitted to the hospital and scheduled for device replacement.This crt-p remains in service at this time.No additional adverse patient effects were reported.

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that the patient implanted with this cardiac resynchronization therapy pacemaker (crt-p) was feeling unwell since august.Upon further evaluation, it was determined that the crt-p had entered safety mode.The patient was admitted to the hospital and scheduled for device replacement.This crt-p remains in service at this time.No additional adverse patient effects were reported.Additional information received reported that this cardiac resynchronization therapy pacemaker (crt-p) was explanted, replaced, and returned for analysis.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 and that bradycardia therapy remained available.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 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 the patient implanted with this cardiac resynchronization therapy pacemaker (crt-p) was feeling unwell since august.Upon further evaluation, it was determined that the crt-p had entered safety mode.The patient was admitted to the hospital and scheduled for device replacement.This crt-p remains in service at this time.No additional adverse patient effects were reported.Additional information received reported that this cardiac resynchronization therapy pacemaker (crt-p) was explanted, replaced, and returned for analysis.No additional adverse patient effects were reported.

• Brand Name: INVIVE
• Type of Device: IMPLANTABLE PACEMAKER
• 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: 18089340
• MDR Text Key: 327586825
• Report Number: 2124215-2023-62690
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2024

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: 02/12/2015
• Device Model Number: W173
• Device Catalogue Number: W173
• Device Lot Number: 114161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 11/21/2023; 03/26/2024
• Supplement Dates FDA Received: 12/12/2023; 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2013
• 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): Required Intervention; Hospitalization