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

Model Number T167

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

Patient Problems No Consequences Or Impact To Patient (2199); Complaint, Ill-Defined (2331)

Event Date 05/22/2014

Event Type  Injury  

Event Description

Boston scientific received information that during a follow up visit, this device with right ventricular lead displayed noise resulting in brief pacing inhibition and false ventricular fibrillation (vf) beat detections.The pacing inhibition resulted in asystole greater than two seconds.The patient with this system has an intrinsic escape rhythm of thirty beats.Attempts to recreate the noise were unsuccessful.An internal technical service consultant was contacted and after reviewing the data, did not find evidence of a lead fracture.Ts indicated the noise was typical of myopotentials.Lead diagnostics have stable for the past year.A decision regarding lead replacement will be made in the near future.

Event Description

Subsequently,a follow up visit was performed.The patient with this system has felt unwell for a few days and has been vomiting.The epidoses approximately coincided wtih the vomiting.A revision procedure was performed.A decision was made to replace this device for a newer generation device.This device was removed and replaced successfully.A new pace/sense lead was added which resolved the issue myopotential noise.No adverse patient effects were reported.

Manufacturer Narrative

(b)(4) according to available information, no return of product is intended.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

(b)(4).When additional information becomes available, this event will be updated.

• 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 55112 ; 6515824786
• MDR Report Key: 3906180
• MDR Text Key: 4520712
• Report Number: 2124215-2014-11447
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• PMA/PMN Number: P960040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/28/2014

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: 01/26/2008
• Device Model Number: T167
• Other Device ID Number: VITALITY 2 DR EL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/28/2014
• Initial Date FDA Received: 07/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2007
• 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: T167; 0165; 4087
• Patient Outcome(s): Life Threatening; Required Intervention