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

Model Number G148

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); No Code Available (3191)

Event Date 06/29/2020

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.(b)(4).The product was returned but there was no analysis performed.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system revision due to an allergic reaction.Reportedly, the field representative believed that the patient had an allergic reaction and wanted to know what the materials in the system were.Boston scientific technical services (ts) sent material lists for the device and leads but do not have specific details for non-boston scientific product.Additional information received indicates that the physician requested a patch kit for allergy testing and stated that they were looking for an alternative device.Ts stated that they do not provide materials for patch testing.Furthermore, the patient had reportedly rejected two devices.There were no additional adverse patient effects reported.All available information indicates that as of this time, the crt-d was explanted.

• 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: 10322841
• MDR Text Key: 200383401
• Report Number: 2124215-2020-15452
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2020

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: 08/13/2020
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 197881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/24/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/23/2018
• 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: 36 YR