MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN EL ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number D143

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Unspecified Infection (1930); Pain (1994); Staphylococcus Aureus (2058); Swelling (2091)

Event Date 12/06/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) was part of a system revision due to infection.Reportedly, the patient had a possible staphylococcus aureus infection.Furthermore, there was also a swollen area around the device.There were no additional adverse patient effects reported.The icd remains in service.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.This supplemental eport is being filed to capture the the h6: device code.

Event Description

It was reported that the patient with this implantable cardioverter defibrillator (icd) had an infection.Reportedly, it was a possible staphylococcus aureus infection.Additional information indicates that the patient's current device is migrating and might have staph infection.There's a swollen area around the device and one doctor told the patient to put numbing cream over it.The patient stated the doctor hesitant about making another incision because it's just now starting to heal and the patient is in high risk for infection, given the number of surgeries and the scar tissue.The patient is not convinced that the current device is working correctly.As per the physician, the patient is at high risk for a major staph infection if another incision is made.All available information indicates that as of this time, the icd with the right ventricular (rv) lead and right atrial (ra) lead remain in service.No additional adverse patient effects were reported.

• Brand Name: INOGEN EL ICD DR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11191007
• MDR Text Key: 227485658
• Report Number: 2124215-2021-00827
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526534263
• UDI-Public: 00802526534263
• Combination Product (y/n): N
• PMA/PMN Number: P960040/S306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/19/2017
• Device Model Number: D143
• Device Catalogue Number: D143
• Device Lot Number: 201392
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR