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 10/13/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Upon receipt at our post market quality assurance laboratory this device underwent thorough testing.Initial analysis found the device had no output or telemetry nor did it meet longevity expectations.Detailed analysis noted no function irregularities or high current drain.No further testing or analysis was performed as information regarding implant parameters and device settings was not available.The cause of the absent telemetry and output could not be determined.

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 identified a product performance issue.

• 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 55112 ; 6515824786
• MDR Report Key: 4396683
• MDR Text Key: 19050441
• Report Number: 2124215-2014-19520
• 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: 10/13/2014

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: Other
• Device Expiration Date: 12/21/2011
• Device Model Number: H140
• Other Device ID Number: CONTAK RENEWAL TR2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2014
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/13/2014
• Initial Date FDA Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2009
• 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: H140