MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND ORIGEN; IMPLANTABLE CHF GENERATOR

Model Number G058

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2018

Event Type  Injury  

Manufacturer Narrative

This crt-d is expected to be returned back from the field for analysis.This report will be updated upon completion of analysis.

Event Description

Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) was found to be in safety core.Surgical intervention was performed and the crt-d was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety core and that both brady and tachy therapy remained available.Review of device memory identified an error.The error resulted in software resets performed in an attempt to correct an identified memory inconsistency.The corrupted memory was corrected in the laboratory and the device reverted to normal operation.The cause of the memory inconsistency was not able to be determined through laboratory testing but was likely the result of exposure to radiation, either therapeutic or environmental.

• Brand Name: ORIGEN
• Type of Device: IMPLANTABLE CHF 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: 7407441
• MDR Text Key: 104707243
• Report Number: 2124215-2018-01850
• Device Sequence Number: 1
• Product Code: NIK
• 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: 02/26/2018

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: 11/23/2018
• Device Model Number: G058
• Other Device ID Number: ORIGEN X4 CRT-D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/19/2018
• Initial Date FDA Received: 04/09/2018
• Supplement Dates Manufacturer Received: 02/26/2018
• Supplement Dates FDA Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2016
• 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: G058
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR