MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN CRT-D; IMPLANTABLE CHF GENERATOR

Model Number G151

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

Patient Problems Unspecified Infection (1930); Swelling (2091)

Event Date 09/24/2018

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.Infection/erosion issue does not require analysis.

Event Description

Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system revision due to infection.The patient also had a swollen pocket.The patient was treated with intravenous antibiotics.There were no additional adverse patient effects reported.The crt-d was explanted.

Manufacturer Narrative

Common device name: defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d).As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

This supplemental report is being filed as updates from product investigation was received.Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system revision due to infection.The patient also had a swollen pocket.The patient was treated with intravenous antibiotics.There were no additional adverse patient effects reported.The crt-d was explanted.

• Brand Name: DYNAGEN CRT-D
• Type of Device: IMPLANTABLE CHF GENERATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CLONMEL LIMITED; cashel road; ,; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8002673
• MDR Text Key: 124944534
• Report Number: 2124215-2018-60323
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534638
• UDI-Public: 802526534638
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

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: 08/17/2018
• Device Model Number: G151
• Device Catalogue Number: G151
• Device Lot Number: 117723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2018
• Initial Date FDA Received: 10/24/2018
• Supplement Dates Manufacturer Received: 01/18/2019
• Supplement Dates FDA Received: 03/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2016
• 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; Life Threatening; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 107