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

Model Number T175

Device Problem Communication or Transmission Problem (2896)

Patient Problem Syncope (1610)

Event Date 03/16/2016

Event Type  Injury  

Manufacturer Narrative

Additional information was received indicating the patient elected to not have the device replaced.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 implanted with this implantable cardioverter defibrillator (icd) presented due to syncope.Attempts to interrogate this device were unsuccessful.A magnet was applied to the device and there was no evidence of tones.Boston scientific technical services (ts) discussed the device has been implanted for almost 10 years and the battery may be depleted.The patient reported they had their device checked two months ago with no anomalies noted.No adverse patient effects were reported.

• 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5602954
• MDR Text Key: 43465450
• Report Number: 2124215-2016-05267
• 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: Physician
• Type of Report: Initial
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/21/2007
• Device Model Number: T175
• Other Device ID Number: VITALITY 2 VR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/16/2016
• Initial Date FDA Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2006
• 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: T175
• Patient Outcome(s): Life Threatening
• Patient Age: 61 YR