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

Model Number H120

Device Problems Electrical /Electronic Property Problem (1198); Over-Sensing (1438)

Patient Problems Atrial Flutter (1730); No Consequences Or Impact To Patient (2199)

Event Date 04/09/2010

Event Type  malfunction  

Event Description

Boston scientific received information that the patient with this device had a previous av node ablation.It was noted that the patient has atrial flutter and some of the flutter waves fell in to refractory or blanking so mode switching took longer.Programming options discussed.At additional follow-up far-field r-wave oversensing was noted causing some inappropriate mode switches.Further reprogramming options were discussed.Approximately four years later the device was explanted due to normal battery depletion, and initial analysis identified a potential issue related to longevity.

Manufacturer Narrative

(b)(4).Detailed analysis is pending and this report will updated when analysis is completed.

Manufacturer Narrative

(b)(4).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 which verified pacing, sensing, impedance measurements and recording functions; the device passed electrical testing.Notes related to left ventricular (lv) lead programming were found in the device memory and when longevity calculations were performed based on those measurements the device met longevity.The field observations were unable to be confirmed by analysis.

• 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: 3906527
• MDR Text Key: 4674713
• Report Number: 2124215-2014-12760
• 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,Followup
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/11/2011
• Device Model Number: H120
• Other Device ID Number: CONTAK RENEWAL TR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2014
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2009
• 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: 4543; H120; 4470; 4088
• Patient Age: 91 YR