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

Model Number P143

Device Problems Device Alarm System (1012); Failure to Capture (1081); High impedance (1291); Pocket Stimulation (1463); Device Sensing Problem (2917)

Patient Problems Muscle Stimulation (1412); No Consequences Or Impact To Patient (2199)

Event Date 04/05/2016

Event Type  malfunction  

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

Boston scientific received information that this patient stated the device was beeping sixteen times once a day.Boston scientific technical services (ts) reviewed the available data and indicated there were alerts for the right atrial (ra) lead for out of range amplitude measurements and left ventricular (lv) lead for out of range impedance measurements.The patient was instructed to contact their clinic for review.The patient had a history of loss of capture and diaphragm stimulation in other polarities, therefore, the programming could not be changed.The lv impedance measurement trigger was increased and the patient will continue to be followed appropriately.No adverse patient effects were reported.

• 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 ; 6515824786
• MDR Report Key: 5796176
• MDR Text Key: 50347382
• Report Number: 2124215-2016-10358
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/18/2013
• Device Model Number: P143
• Other Device ID Number: ENERGEN CRT-D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/21/2016
• Initial Date FDA Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2011
• 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 Age: 74 YR