MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND INGENIO; IMPLANTABLE PULSE GENERATOR

Model Number V273

Device Problems Pacing Problem (1439); Device Operates Differently Than Expected (2913)

Patient Problems Syncope (1610); Atrial Tachycardia (1731)

Event Date 10/12/2017

Event Type  Injury  

Manufacturer Narrative

A boston scientific technical services consultant documented and discussed the clinical observations with the caller.Efforts to obtain additional product issue details were unsuccessful.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 patient experienced a syncopal event.A review of the presenting data showed the device was operating as programmed.There were some pacemaker mediated tachycardia (pmt) stored episodes from the past seventy-two hours which appear to be due to atrial tachycardia (at) causing the device to pace at the maximum tracking rate (mtr).No adverse patient effects were reported.

• Brand Name: INGENIO
• Type of Device: IMPLANTABLE PULSE GENERATOR
• 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: 7190538
• MDR Text Key: 97283368
• Report Number: 2124215-2017-20383
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536670
• UDI-Public: 00802526536670
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 10/12/2017

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: 07/09/2016
• Device Model Number: V273
• Other Device ID Number: INTUA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/12/2017
• Initial Date FDA Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2014
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 66 YR