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

Model Number W173

Device Problems Premature Discharge of Battery (1057); Pacing Problem (1439); Interrogation Problem (4017)

Patient Problem Bradycardia (1751)

Event Date 12/22/2022

Event Type  Injury  

Event Description

It was reported that during routine follow-up, this cardiac resynchronization therapy pacemaker (crt-p) was unable to be interrogated.Pacing inhibition was also reported.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

Upon receipt at our post market quality assurance laboratory, analysis confirmed the clinical observation of no telemetry or pacing output.The device case was opened, and visual inspection revealed no irregularities.Testing found that the battery had depleted earlier than expected.When connected to an external power source, the device passed all tests and operated normally.No high current drain or other device anomaly was identified during analysis.Although the clinical observations were caused by a depleted battery, laboratory analysis was unable to reproduce the condition that caused the battery to deplete prematurely.

Event Description

It was reported that during routine follow-up, this cardiac resynchronization therapy pacemaker (crt-p) was unable to be interrogated.Pacing inhibition and suspected early battery depletion was also reported.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.

• Brand Name: INVIVE
• 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: 16070985
• MDR Text Key: 306362276
• Report Number: 2124215-2022-55473
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/20/2015
• Device Model Number: W173
• Device Catalogue Number: W173
• Device Lot Number: 116053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2013
• 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