MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND VITALITY 2; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number T177

Device Problems Failure to Capture (1081); Capturing Problem (2891); Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2017

Event Type  Injury  

Manufacturer Narrative

This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that a procedure took place due to reduced sensing when it comes to this right ventricular (rv) lead as well as loss of capture and high pacing thresholds.The system was reprogrammed.The rv lead was surgically abandoned.No adverse patient effects were reported.The status of the device is pending more information.

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 was attached to 500 ohm pacing load and the device was able to sense and pace normal.It was not possible to recreate any noise or oversensing on the device.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.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

Event Description

The device was subsequently returned for analysis.

• Brand Name: VITALITY 2
• 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: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 6546252
• MDR Text Key: 74472534
• Report Number: 2124215-2017-07735
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P960040/S039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2008
• Device Model Number: T177
• Other Device ID Number: VITALITY 2 VR EL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2007
• 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: 0185; T177
• Patient Age: 87 YR