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

Model Number H140

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2014

Event Type  malfunction  

Event Description

Boston scientific received information that this product was returned with no reported product performance issues and no reported adverse patient effects.Initial analysis completed in our post market quality assurance laboratory determined this product did not meet longevity expectations.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.A visual inspection of the device header and case noted no anomalies.The device was then exposed to simulated heart load conditions, and the pacing and sensing functions were tested.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.However, initial testing had determined this device did not meet longevity expectations.The titanium case was opened and visual inspection of the internal components revealed no irregularities.When connected to an external power source, the device passed all tests and operated normally.No high current drain or other device malfunction was identified during analysis.Despite exhaustive testing, the cause of the premature battery depletion could not be determined.

• 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: sharon zurn ; 4100 hamline ave. n; st. paul, MN 55112 ; 6515824786
• MDR Report Key: 3717053
• MDR Text Key: 15267107
• Report Number: 2124215-2014-04439
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Type of Report: Initial
• Report Date: 01/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/07/2010
• Device Model Number: H140
• Other Device ID Number: CONTAK RENEWAL TR2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2013
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/03/2014
• Initial Date FDA Received: 04/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2008
• 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: H140