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

Model Number G148

Device Problem Premature Discharge of Battery (1057)

Patient Problems No Known Impact Or Consequence To Patient (2692); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/20/2019

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) battery was rapidly draining.Further, reprogramming was performed.No further information available.No adverse patient effects were reported.

Manufacturer Narrative

The device has been received for analysis.Upon completion of analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.The patient code appropriate term/code not available captures the reportable event of surgery.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) battery was rapidly draining.The device remains in service.No adverse patient effects were reported.Additional information was received indicating that the device was explanted.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed in which analysis did not confirm premature battery depletion (pbd).The baseline testing completed on the devcie found no failing conditions.All testing completed on the device passed or was not applicable, therefore no problem was detected.Analysis found no evidence of device defect, malfunction, or damage outside the bounds of normal medical use.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) battery was rapidly draining.Additional information was received indicating that the device was explanted.No additional adverse patient effects were reported.

• 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: 8597522
• MDR Text Key: 144674121
• Report Number: 2124215-2019-09896
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: 00802526534591
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/02/2022

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: 05/07/2017
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 133903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2019
• Initial Date FDA Received: 05/09/2019
• Supplement Dates Manufacturer Received: 03/05/2021; 10/21/2021
• Supplement Dates FDA Received: 05/06/2021; 01/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2015
• 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
• Patient Age: 51 YR
• Patient Sex: Female