MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND CONTAK RENEWAL TR; IMPLANTABLE CHF GENERATOR

Model Number H140

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

Patient Problems Purulent Discharge (1812); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930)

Event Date 01/15/2010

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 one month post implant the patient implanted with this product presented to the wound clinic with redness around pocket area with drainage.Surgical intervention was performed and the system was extracted.An allergy test confirmed that the patient is allergic to chromium and nickel.There were no additional adverse effects reported.

• Brand Name: CONTAK RENEWAL TR
• 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 6019109
• MDR Text Key: 57047596
• Report Number: 2124215-2016-12787
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2016

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: 11/10/2011
• Device Model Number: H140
• Other Device ID Number: CONTAK RENEWAL TR2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/06/2016
• Initial Date FDA Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2009
• 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: 0158; 1788TC; 4096; 4543; H140; P107
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention