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

Model Number G158

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pocket Erosion (2013); Skin Irritation (2076); No Code Available (3191); Skin Inflammation/ Irritation (4545)

Event Date 06/24/2020

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).

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system revision due some irritation around the pocket towards the side of the armpit area.Furthermore, it was not eroding but the skin appeared irritated.The patient was put on oral antibiotics as a precaution.There were no additional adverse patient effects reported.The crt-d was repositioned more to the middle part of the body.This crt-d remains in service.

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.Patient code 3191 captures the reportable event of surgery and the additional intervention performed by the use on intravenous antibiotics.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) had some irritation around the pocket in the lateral axillary area.Furthermore, it was not eroding but the skin appeared irritated.The patient was put on oral antibiotics as a precaution.Additional information received from the field representative indicates that the area was red and irritated and did not noticed any thinning or erosion.There were no additional adverse patient effects reported.The device remains in service.Pertinent information received from ai and per form, stating that the system was explanted due to pocket erosion.

• Brand Name: DYNAGEN 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: 10318232
• MDR Text Key: 200215361
• Report Number: 2124215-2020-15352
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534904
• UDI-Public: 00802526534904
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2022

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/11/2019
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 178588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 01/03/2022
• Supplement Dates FDA Received: 03/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2017
• 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: 55 YR
• Patient Sex: Female