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

Model Number T180

Device Problems Over-Sensing (1438); Pacing Problem (1439); Low impedance (2285); Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2014

Event Type  malfunction  

Event Description

Boston scientific received information that this implantable defibrillator and right ventricular (rv) lead exhibited low shocking lead impedance measurements less than 20 ohms on a day the patient was having surgery.Noise on both rv and shock channel was also noted a month before the said procedure.Additional information was received and indicated that the cause was not determined.Noise was oversensed and led to pacing inhibition.However, no inappropriate therapy or greater than two seconds asystole had been observed.No intervention was performed.The patient would continue to be monitored.No adverse patient effects were reported.

Manufacturer Narrative

(b)(4).As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

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 body fluid contamination in the lead barrels and a hole in the right atrial seal plug.Analysis noted that no shocks were delivered after the painless shock impedance measured less than 20 ohms.Analysis review of the device¿s memory found the device did shock into an open lead condition.No noise was noted during testing.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 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.

Event Description

The implantable cardioverter defibrillator (icd) was explanted over a year later for reported normal battery depletion and was returned for analysis four months after explant.

• 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 55112 ; 6515824786
• MDR Report Key: 4149204
• MDR Text Key: 4929187
• Report Number: 2124215-2014-14888
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/13/2008
• Device Model Number: T180
• Other Device ID Number: VITALITY DR HE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/17/2014
• Initial Date FDA Received: 10/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2007
• 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: 1861; T180; 4469; 1853
• Patient Age: 72 YR