MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND VITALITY; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number T180

Device Problem Low impedance (2285)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2007

Event Type  malfunction  

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

Boston scientific received information that this implantable cardioverter defibrillator (icd) recorded shock impedance measurements of less than 20 ohms exhibited by these large epicardial patch leads.Defibrillation threshold (dft) testing was undertaken and a 31 joule and 41 joule shock resulted in shock impedance measurements of less than 20 ohms.The patch leads appeared fine under fluoroscopy.Technical services advised preserving device memory to a disk and returning for analysis to further troubleshoot.A copy of device memory was returned and forwarded for engineering analysis.Analysis of device memory determined that the exact shock impedance measurements were 18 ohms and that this measurement is acceptable for this device and leads.Engineering advised it would be appropriate to leave these items implanted and suggested monitoring to ensure that the system continues to function appropriately.No adverse patient effects were reported.The device was later explanted and returned for analysis 9 years later.

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 defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.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.

• Brand Name: VITALITY
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 6019193
• MDR Text Key: 57058373
• Report Number: 2124215-2016-11166
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/26/2008
• Device Model Number: T180
• Other Device ID Number: VITALITY DR HE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2007
• 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: 0068; 0185; 4470; 4968; T180
• Patient Age: 68 YR