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

Model Number N140

Device Problem Pacing Problem (1439)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 09/03/2014

Event Type  Injury  

Event Description

Boston scientific received information that the patient with this implantable cardioverter defibrillator (icd) was in the hospital.The device began to ap-vp at a rhythm of 130-150 beats per minute.The patient did not tolerate the high rate pacing well.Cardiopulmonary resuscitation (cpr) was performed and the patient was intubated.The local boston scientific field representative sent in telemetry strips for technical services to review.Of note, there were no stored episodes in the device's event logbook and the strips that were sent in for review were during a period when the patient was receiving cpr.Ts reviewed the strips and suspected that ventricular rate regulation (vrr) was the source of the observed device behavior.Ts recommended that a save to disk be sent in for review.The fr programmed rate response and vrr to off.Additional information has been requested from the fr.The device remains in service.

Manufacturer Narrative

(b)(4).As of today, no additional information has been received.Should additional information become available, this report will be updated.

• Brand Name: ENERGEN
• 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 55112 ; 6515824786
• MDR Report Key: 4232392
• MDR Text Key: 4972213
• Report Number: 2124215-2014-19549
• 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
• Report Date: 09/03/2014

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: 07/29/2016
• Device Model Number: N140
• Other Device ID Number: ENERGEN CRT-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 09/03/2014
• Initial Date FDA Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2014
• 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
• Treatment: 4135; 4543; N140; 0292
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 66 YR