MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN? CRT-D; cardiac resynchronization therapy defibrillator

Model Number	G151
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Hematoma (1884); Unspecified Infection (1930)
Date of Event	07/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) had an infection.Upon operation, the device pocket was with erythema, hematoma and reddish capsule.A revision was performed and the crt-d with the right ventricular (rv) lead, right atrial (ra) lead and left ventricular (lv) lead were explanted.A previously capped lv lead remains capped.Subsequently, antibiotic irrigation of the areas was performed.No additional adverse patient effects were reported.The device was not returned for analysis.

• Brand Name: DYNAGEN? CRT-D
• Common Device Name: cardiac resynchronization therapy defibrillator
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel E91 T 862; EI E91 T862
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50368213
• Report Number: 2124215-2026-45080
• Device Sequence Number: 21505377
• Product Code: NIK
• UDI-Device Identifier: 00802526534638
• UDI-Public: (01)00802526534638(17)210403
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/03/2021
• Device Model Number: G151
• Device Catalogue Number: G151
• Device Lot Number: 133169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 08/21/2026
• Supplement Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 04/12/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male