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

Model Number G179

Device Problems Premature Discharge of Battery (1057); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2018

Event Type  Injury  

Manufacturer Narrative

A revision procedure was performed and the device was explanted and successfully replaced.The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.

Event Description

Boston scientific received information that it was discovered during a normal follow-up appointment this cardiac resynchronization therapy defibrillator (crt-d) was at explant status.Approximately six months prior, this device had four years of battery remaining.Device data was sent in for review.Engineering analysis confirmed the device declared explant status due to a charge time measurement of 21 seconds.Device replacement was recommended.No adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our quality assurance laboratory, the device was thoroughly inspected and analyzed.Review of device memory confirmed that the device had reached eri status due to long charge times.Testing confirmed that an internal component was not securely attached to the circuit substrate.This open connection was between a diode component within charging circuitry and the electronics substrate.This incomplete electrical pathway within the device¿s shock charging circuitry resulted in the lengthened charge times that triggered eri (note that the battery was not depleted, but replacement indicators were triggered because capacitor charging was not accomplished within the specified time).Engineers determined that the conductive epoxy used to connect the diode component to the printed circuit board did not create a secure connection.Despite exhibiting extended charge times, the maximum shock energy was still available and therapy availability is not compromised in devices exhibiting this issue.Therapy would have been available to the patient (if required), albeit with a somewhat longer charge time.This intermittent connection manifests during capacitor reformations or therapy charges.

• Brand Name: AUTOGEN
• 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: 7409373
• MDR Text Key: 104773031
• Report Number: 2124215-2018-04857
• 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: 04/13/2018

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: 05/20/2016
• Device Model Number: G179
• Other Device ID Number: AUTOGEN X4 CRT-D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 04/09/2018
• Supplement Dates Manufacturer Received: 04/13/2018
• Supplement Dates FDA Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A¿INTERNATIONAL ONLY
• Patient Sequence Number: 1
• Treatment: G179
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention