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

Model Number D176

Device Problems Electrical /Electronic Property Problem (1198); Pacing Problem (1439); Failure to Convert Rhythm (1540); Failure to Sense (1559); Defibrillation/Stimulation Problem (1573); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Syncope (1610); Atrial Tachycardia (1731); Cardiac Arrest (1762); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 04/21/2016

Event Type  Injury  

Manufacturer Narrative

Additional information concerning this event is being requested from the field.This event will be updated should additional information be provided.

Event Description

Boston scientific received information that one day post-implant, this patient suffered a cardiac arrest with prolonged pulseless electrical activity resulting in the patient having to be externally defibrillated.Review of the episode revealed the patient was in ventricular fibrillation and the device did not detect or deliver critical therapy properly.At this time, the device was reprogrammed and remains implanted and in service.No additional adverse patient effects were reported.

Manufacturer Narrative

Despite multiple attempts to gather information from the field, no further details surrounding this event have been made available at this time.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Manufacturer Narrative

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Event Description

Additional information provided from the field indicated this patient suffered another syncopal episode that required external defibrillation from paramedics to convert.Review of the device revealed that the patient had atrial tachycardia which conducted into the ventricle and caused ventricular tachycardia (vt).Anti-tachycardia pacing was then delivered but this accelerated the vt into ventricular fibrillation (vf) which the device could not convert with multiple shocks thus requiring external defibrillation.Another episode showed vf which was properly converted with an internal shock.The device was also observed to have recorded multiple faults during these episodes; one for a lead leakage fault and the other for a high voltage fault which appears to have interrupted a shock attempt during the episode.These faults may have occurred due to external sources and the device appears to have been functioning properly in reaction to them.At this time, the device has been reprogrammed and remains implanted and in service.No additional adverse patient effects were reported.

• 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: 5789124
• MDR Text Key: 49371771
• Report Number: 2124215-2016-07246
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/20/2017
• Device Model Number: D176
• 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: 08/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2015
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 34 YR