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

Model Number T165

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2013

Event Type  malfunction  

Event Description

Boston scientific received information that this implantable cardioverter defibrillator (icd) oversensed right atrial (ra) activity on the right ventricular (rv) lead resulting in inappropriate anti-tachycardia pacing (atp) and shock therapy.Therapy was reported to have been exhausted.No adverse patient effects.Device reprogrammed to mitigate recurrence.Device remains in service.

Manufacturer Narrative

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

New information received indicates that this device has since been explanted for normal battery depletion.The device was given to the patient and will not be returned for analysis.

Manufacturer Narrative

(b)(4).

• 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: sharon zurn ; 4100 hamline ave. n; st. paul, MN 55112 ; 6515824786
• MDR Report Key: 3570765
• MDR Text Key: 4074905
• Report Number: 2124215-2013-20532
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/11/2014

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: 02/01/2009
• Device Model Number: T165
• Other Device ID Number: VITALITY 2 DR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/11/2014
• Initial Date FDA Received: 01/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2008
• 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
• Treatment: 1861; T165; 0147; MISMATCH
• Patient Age: 82 YR