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

Model Number N118

Device Problem Human-Device Interface Problem (2949)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Perforation of Vessels (2135); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 07/03/2018

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 patient with cardiac resynchronization therapy defibrillator (crt-d) experienced hemopericardium with cardiac tamponade from mediastinal bleeding.After surgical procedure, this patient had perforation.Hematoma was also noted.Additional information indicates that the extraction catheter tore the superior vena cava which eventually caused pericardial effusion.This device was explanted.No additional adverse patient effects were reported.

• Brand Name: COGNIS
• Type of Device: IMPLANTABLE CHF PULSE 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: 7990168
• MDR Text Key: 124508238
• Report Number: 2124215-2018-19042
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/24/2018

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/21/2011
• Device Model Number: N118
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/24/2018
• Initial Date FDA Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2010
• 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: 0147; 4469; 4517; H175; N118
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 56 YR