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

Model Number T167

Device Problems Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 07/28/2015

Event Type  Injury  

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.

Event Description

Boston scientific received information that this implantable cardioverter defibrillator (icd) system exhibited noise and oversensing that lead to an inappropriate shock and inhibition of pacing.The inhibition of pacing lead to greater than two seconds of asystole.No further adverse patient effects were reported.All lead measurements were normal.The sensitivity was adjusted and detection was extended.The rv lead was to be revised in the near future.

Event Description

Additional information was received that this patient underwent a revision procedure and the icd and rate/sense portion of the rv lead were removed from service.A new icd and epicardial lead was placed.No further complications were reported.The product is not expected to be returned at this time.

• 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: 5174510
• MDR Text Key: 29189377
• Report Number: 2124215-2015-12159
• 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: 09/28/2015

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: 10/10/2008
• 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: 09/03/2015
• Initial Date FDA Received: 10/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2007
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR