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

Model Number T125

Device Problems Use of Device Problem (1670); Device Operates Differently Than Expected (2913)

Patient Problem Ventricular Fibrillation (2130)

Event Date 06/19/2015

Event Type  malfunction  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, the device was analyzed.Analysis of device software and memory determined the clinical observations were a result of several altered memory locations.Analysis found the histogram area of memory had a single bit of error.The device firmware was restarted and the device operated normally, confirming the altered memory locations were not a result of component malfunction.It was reported this patient was exposed to radiation while this device was implanted.

Event Description

Boston scientific received information that this implantable cardioverter defibrillator (icd) displayed 82 percent ventricular fibrillation pacing in the 250 range.A boston scientific technical services (ts) discussed that there must be some memory corruption and had been going on for a while.The patient was noted to have multiple instance of radiation therapy.Ts discussed performing a memory dump.Latitude showed device working as intended.The device was explanted.No adverse patient effects were reported.

• 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: 5800297
• MDR Text Key: 49746740
• Report Number: 2124215-2016-06846
• 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: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/30/2009
• Device Model Number: T125
• Other Device ID Number: VITALITY DS DR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2008
• 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: 69 YR