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

Model Number G247

Device Problems High impedance (1291); Over-Sensing (1438); Ambient Noise Problem (2877)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/19/2018

Event Type  malfunction  

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

Boston scientific received information that this local representative contacted boston scientific's technical services to report that this device and non-boston scientific's implantable transvenous right atrial (ra) were exhibiting noise, oversensing and intermittent high pacing impedance.The local representative suspects that these observations were the result of minute ventilation (mv) rrt noise.The local representative mentioned that the patient also had a heart logic alert.The local representative was informed that the device's heart logic feature will still be operational when rrt is programmed off.The patient will be seen in the clinic today to have rrt programmed off.Boston scientific received information from the local representative that the device¿s rrt feature was programmed off.No other interventions (reprogramming or invasive) were undertaken.

• Brand Name: VIGILANT
• 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: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7984550
• MDR Text Key: 124348950
• Report Number: 2124215-2018-18273
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589287
• UDI-Public: (01)00802526589287(17)20190608
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/07/2018

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: 06/08/2019
• Device Model Number: G247
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2017
• 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: 0293; 4677; 5076; G247; S603
• Patient Age: 84 YR