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

Model Number V273

Device Problems Failure to Capture (1081); Over-Sensing (1438); Ambient Noise Problem (2877); Capturing Problem (2891); Impedance Problem (2950)

Patient Problem Dizziness (2194)

Event Date 09/11/2016

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested.This report will be updated should further information be received.

Event Description

Boston scientific received information that this device and competitor right ventricular (rv) lead and competitor left ventricular (lv) lead exhibited loss of capture and oversensing.The rv and lv loss of capture and oversensing were resolved.At the time of this report, it is unknown how this was resolved.The competitor right atrial (ra) lead exhibited minute ventilation signal oversensing, high thresholds, and variable pace impedance measurements.Additionally the patient felt light-headed, which has been getting more frequent.This device remains in service.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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 6039993
• MDR Text Key: 57854568
• Report Number: 2124215-2016-16748
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536670
• UDI-Public: (01)00802526536670(17)20150705
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 09/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/05/2015
• Device Model Number: V273
• Other Device ID Number: INTUA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2013
• 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: 2187; 5054; 5554; 8042; V273
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR