MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND AUTOGEN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number D175

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/22/2015

Event Type  Injury  

Manufacturer Narrative

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 during defibrillation threshold (dft) testing this implantable cardioverter defibrillator (icd) recorded code 1004 indicative of a shorted shock condition and code 1007 indicative of long charge times preventing capacitor charge.An external shock was delivered which successfully cardioverted the patient's induced arrythmia.Boston scientific technical services (ts) recommended urgent device and lead replacement as critical therapy is likely compromised.No adverse patient effects were reported.Available information indicates that intervention is scheduled but not yet performed.

Manufacturer Narrative

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

Surgical intervention was performed and an subcutaneous implantable cardioverter defibrillator (s-icd) was successfully implanted.This icd was not explanted as the patient did not tolerate the intervention well.Additional surgical intervention will be performed to explant the icd at some point in the future.

• Brand Name: AUTOGEN
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 5373701
• MDR Text Key: 36218508
• Report Number: 2124215-2016-00743
• Device Sequence Number: 1
• Product Code: OSR
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/24/2016
• Device Model Number: D175
• Other Device ID Number: AUTOGEN EL ICD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2014
• 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; Required Intervention
• Patient Age: 59 YR