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

Model Number T175

Device Problems High impedance (1291); Pacing Problem (1439); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2014

Event Type  Injury  

Event Description

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Manufacturer Narrative

(b)(4).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 no anomalies.The seal plugs were found to be intact and all setscrews moved freely and without issue.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.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.Laboratory analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

Event Description

Boston scientific received information that one week following the implant of this implantable cardioverter defibrillator (icd) and this right ventricular (rv) lead, the pacing impedance measurements were above 3,000 ohms and the device was not able to pace and maximum outputs.A revision procedure was performed and it was discovered that the setscrews were unable to be engaged which is causing the observations.The rv lead was tested on the pacing system analyzer (psa) and all measurements, including pacing impedance measurements, were in normal range.The icd was successfully replaced and will be returned for laboratory analysis.The rv lead remains implanted and in service.No additional adverse patient effects were reported.

Manufacturer Narrative

The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.

• 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: 3718914
• MDR Text Key: 4517996
• Report Number: 2124215-2014-05919
• 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: Invalid Data
• 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: 09/11/2014
• Device Model Number: T175
• Other Device ID Number: VITALITY 2 VR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2014
• 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: 04/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2013
• 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: 0185; T175
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention