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

Model Number G150

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

Patient Problems Unspecified Infection (1930); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 08/19/2022

Event Type  Injury  

Manufacturer Narrative

The product has been received for analysis.Upon completion of the analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) had an infection.A revision was performed and the crt-d with the right ventricular (rv) lead and right atrial (ra) lead were explanted.Additional information received indicates that there was no systemic infection and nothing was growing in the blood.This was just a pocket infection.A new device was implanted and the temporary lead removed.The old device will be returned to bsc.Furthermore, the patient has a pericardial effusion, but that this was an unrelated finding and was not caused by this procedure.No additional adverse patient effects were reported.

Manufacturer Narrative

The product has been received for analysis.Upon completion of the analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.Correction to field b2: outcomes attributed to adverse event and f10: patient code.Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.Detailed analysis did not confirm allegation made with the device.Moreover, the baseline testing completed on the device found no failing conditions.All testing completed on the device passed or was not applicable, therefore no problem was detected.Furthermore, 'known inherent risk' conclusion code was based on the field report of infection or infection-related conditions.Infection is a known medical risk when the skin barrier is breached.Analysis of the returned product is not able to provide relevant information for infection-related allegations.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) had an infection.A revision was performed and the crt-d with the right ventricular (rv) lead and right atrial (ra) lead were explanted.Additional information received indicates that there was no systemic infection and nothing was growing in the blood.This was just a pocket infection.A new device was implanted and the temporary lead removed.The old device will be returned to bsc.Furthermore, the patient has a pericardial effusion, but that this was an unrelated finding and was not caused by this procedure.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN 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 degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15354503
• MDR Text Key: 299272246
• Report Number: 2124215-2022-34154
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534614
• UDI-Public: 00802526534614
• 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: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/23/2024
• Device Model Number: G150
• Device Catalogue Number: G150
• Device Lot Number: 508002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 73 YR
• Patient Sex: Female