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

Model Number K064

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Syncope (1610)

Event Date 05/10/2018

Event Type  Injury  

Manufacturer Narrative

At this time, the product remains in service.If additional information is received, this report will be updated.

Event Description

Boston scientific received information that this pacemaker patient passed out on 2 occasions.The daughter reported that her mother has dementia and it is difficult to determine other symptoms.Additional information was requested from the field representative and the healthcare provider (hcp).No further information is known at this time.No additional 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: 7656289
• MDR Text Key: 112991533
• Report Number: 2124215-2018-11853
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526516719
• UDI-Public: 00802526516719
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/11/2016
• Device Model Number: K064
• Other Device ID Number: ADVANTIO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2014
• 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): Life Threatening
• Patient Age: 86 YR