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

Model Number T125

Device Problem Failure to Capture (1081)

Patient Problems Dyspnea (1816); Edema (1820); Ventricular Tachycardia (2132); Heart Failure (2206)

Event Date 03/31/2016

Event Type  malfunction  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that the patient presented to the emergency room with complaints of feeling short of breath and a twinge when he woke up.The patient performed a remote home monitoring interrogation prior to presenting to the emergency room.Boston scientific technical services (ts) was consulted and reviewed the remote interrogation data which revealed no administered shocks or stored episodes.It was noted that while in the emergency room the monitor indicated intermittent loss of ventricular capture.Ts discussed that the remote interrogation electrogram (egm) does not assess capture and suggested performing a full interrogation.At this time the rv lead and implantable cardioverter defibrillator (icd) remain in service with no further adverse patient effects reported.

Event Description

Additional information was received from the following clinic that the patient was hospitalized for congestive heart failure and retaining fluid.It was also noted that the patient had ventricular tachycardia (vt) which was appropriately detected and treated by the device.The patient was brought into the clinic over a month later where no issues were seen with the device.Upon interrogation, capture was verified.

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, right ventricular pacing, and sensing functions were tested.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.

Event Description

The implantable cardioverter defibrillator (icd) was explanted for reported normal battery depletion seven months later and returned for analysis.

• 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: 5641453
• MDR Text Key: 44780783
• Report Number: 2124215-2016-07675
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/04/2011
• Device Model Number: T125
• Other Device ID Number: VITALITY DS DR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2010
• 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
• Patient Age: 77 YR