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

Model Number G146

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 09/13/2019

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

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system extraction due to infection.No additional adverse patient effects were reported.

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.This supplemental report is being filed to correct the describe event or problem and explant date.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system extraction due to infection.No additional adverse patient effects were reported.It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system extraction due to infection.The crt-d was explanted and then was used as an external temporary device.The crt-d was removed from service when a new system was implanted.There were no additional adverse patient effects reported.The crt-d is no longer in service.

• 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
• MDR Report Key: 9285598
• MDR Text Key: 165272199
• Report Number: 2124215-2019-24384
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534577
• UDI-Public: 00802526534577
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/24/2017
• Device Model Number: G146
• Device Catalogue Number: G146
• Device Lot Number: 371143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 11/06/2019
• Supplement Dates Manufacturer Received: 09/13/2019
• Supplement Dates FDA Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR