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

Model Number T177

Device Problems High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Connection Problem (2900)

Patient Problem Atrial Fibrillation (1729)

Event Date 09/28/2016

Event Type  malfunction  

Manufacturer Narrative

An investigation into this issue is currently ongoing.Once any additional information becomes available, the report will be updated.

Event Description

Boston scientific received information that the patient with this implantable cardioverter defibrillator (icd) and right ventricular (rv) lead received several inappropriate shocks during atrial fibrillation (af).A review of the icd memory noted that although the shock impedance measurements for the delivered inappropriate shocks were in normal range, the daily measurements showed the shock impedance measurements above 125 ohms.All other lead measurements were in normal range.A memory download was performed and sent to boston scientific technical services (ts) for review.A ts consultant reviewed the data and discussed that the shock impedance measurements increased to above 125 ohms several weeks after the icd and rv lead were implanted, indicating a potential underinsertion or loose connection issue.Additional troubleshooting was discussed.The serial number for the rv lead was not provided and is currently unknown.The patient was hospitalized as a precaution; no adverse patient effects were reported.

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

Additional information was received that the physician extended the duration time within the icd and is currently managing the patient's heart rate during atrial fibrillation (af) with medication.No interventions have been performed or are being planned.The icd and rv lead remain implanted and in service.

• 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: 6193232
• MDR Text Key: 62972455
• Report Number: 2124215-2016-16899
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/28/2016

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: 06/20/2015
• Device Model Number: T177
• Other Device ID Number: VITALITY 2 VR 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: 10/08/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2014
• 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; T177