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

Model Number N140

Device Problems High impedance (1291); Connection Problem (2900); Device Contamination With Biological Material (2908)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2018

Event Type  Injury  

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

Event Description

Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) and right ventricular (rv) lead had high out of range shock lead impedances greater than 125 ohms.The lead was explanted and replaced, and the device was explanted due to contamination and replaced.Additional information was requested to clarify the contamination.No adverse patient effects were reported.

Event Description

Additional information was received that further explained the report of device contamination.The lead was damaged with electrocautery during explant, causing the lead to break and get stuck in the header of the device.The device was not able to be reused, and was explanted.

• 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: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7617268
• MDR Text Key: 111610998
• Report Number: 2124215-2018-09564
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/02/2013
• 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
• Date Manufacturer Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2012
• 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: 58 YR