MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND DYNAGEN; IMPLANTABLE CHF GENERATOR

Model Number G158

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

Patient Problems Fever (1858); Unspecified Infection (1930); Sepsis (2067); Swelling (2091); Weakness (2145)

Event Date 01/28/2018

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.

Event Description

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

Event Description

Additional information indicates that the patient was admitted with sepsis due to unspecified organism.The patient manifested complaints of weakness, fever, increased in swelling and tenderness at pacer site.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN
• Type of Device: IMPLANTABLE CHF GENERATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer (Section G): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7358648
• MDR Text Key: 103075723
• Report Number: 2124215-2018-02900
• Device Sequence Number: 1
• Product Code: NIK
• 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,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2019
• Device Model Number: G158
• Other Device ID Number: DYNAGEN X4 CRT-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2017
• 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
• Treatment: 0293; 4671; 7741; G158
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 84 YR