MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND DYNAGEN; IMPLANTABLE CHF GENERATOR

Model Number G151

Device Problems High impedance (1291); Over-Sensing (1438); Ambient Noise Problem (2877)

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

Event Date 02/21/2018

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 the medical personnel noted oversensing of noise on the right atrial (ra) channel for this cardiac resynchronization therapy defibrillator (crt-d) and another manufacturer's ra lead.Boston scientific technical services (ts) was consulted and discussed the noise appeared to be from the minute ventilation signal.Ts suggested programming the rate response trend feature off in the crt-d.The field representative noted that at this time the clinic has not brought the patient into the office.The crt-d and ra lead remain in service and no adverse patient effects were reported.

Event Description

Additional information was received that the oversensing of noise on the ra channel continued and led to mode switching.Ts again suggested bringing the patient in and programming off the rate response trend (rrt) feature on the crt-d.The clinician also reported that the crt-d and another manufacturer's lv lead exhibited impedance measurements of greater than 3000 ohms.Ts noted that the rrt signal does not use the lv and that the lead should be further evaluated.The cause of the high impedance remains unknown and the device and lead remain in service.At this time the clinic has opted to not bring the patient in for evaluation and will continue to monitor via the remote home monitoring system.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN
• Type of Device: IMPLANTABLE CHF GENERATOR
• 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: 7614885
• MDR Text Key: 111525253
• Report Number: 2124215-2018-06561
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534638
• UDI-Public: 00802526534638
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/29/2017
• Device Model Number: G151
• Other Device ID Number: DYNAGEN 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: 06/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2015
• 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: 5076; 6947; G151; MISMATCH
• Patient Age: 69 YR