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

Model Number T177

Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)

Patient Problem Renal Failure (2041)

Event Date 09/02/2012

Event Type  Injury  

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

Event Description

Boston scientific received information that during the procedure to implant a implantable cardioverter defibrillator (icd), the patient suffered from kidney failure and the physician ended the procedure and the patient was hospitalized.This icd was successfully implanted 4 days later.No additional adverse patient effects were reported.The patient reported that the device later emitted beeping tones.The patient was then informed by their physician that the beeping was due to the device battery getting low.While speaking with a boston scientific company representative, the patient discussed they were informed this device was part of an advisory population, however, no information was provided that indicates the device exhibited any advisory behavior.The device was implanted for 7 years and was explanted and replaced for reported normal battery depletion.

• 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 ; 6515826168
• MDR Report Key: 7614700
• MDR Text Key: 111512474
• Report Number: 2124215-2018-08062
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/21/2006
• Device Model Number: T177
• Other Device ID Number: VITALITY 2 VR EL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2005
• 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 Outcome(s): Hospitalization; Life Threatening
• Patient Age: 65 YR