MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G148

Device Problems Premature Discharge of Battery (1057); Telemetry Discrepancy (1629); Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2022

Event Type  Injury  

Event Description

It was reported that this device was unable to be interrogated and was alleged to be exhibiting premature battery depletion as the previous projected longevity assessment at the last follow-up was seven and a half years remaining.The device was subsequently explanted and replaced to resolve the event and no additional adverse patient effects were reported.The product is expected to be returned for analysis, but has not yet been received.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Visual inspection revealed no abnormalities.The device was unable to establish telemetry for interrogation and no pacing output was noted.The device case was subsequently opened for a thorough battery analysis where the longevity was found to be lower than expected which confirmed the clinical allegation of premature depletion.However, extensive battery testing was unable to discover any irregularities that would have caused the observed premature depletion.Based on a review of all available information, the cause of the reported event could not be determined.

Event Description

It was reported that this device was unable to be interrogated and was alleged to be exhibiting premature battery depletion as the previous projected longevity assessment at the last follow-up was seven and a half years remaining.The device was subsequently explanted and replaced to resolve the event and no additional adverse patient effects were reported.This device was received for analysis.

• Brand Name: INOGEN X4 CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• 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: 15984093
• MDR Text Key: 305489267
• Report Number: 2124215-2022-52828
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: 00802526534591
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/13/2018
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 157070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 56 YR