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

Model Number G150

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2018

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 cardiac resynchronization therapy defibrillator (crt-d) and another manufacturer¿s high voltage right ventricular (rv) lead exhibited high out of range shock impedance measurements.During the in-office interrogation the high shock impedance was unable to be reproduced.Further evaluation of the crt-d system found that another manufacturer¿s right atrial (ra) lead impedance measurements were variable with evidence of oversensing noise from the minute ventilation signal.Subsequently the rate response trend was programmed off.Boston scientific technical services (ts) was contacted and reviewed the data stored in the remote home monitoring system.It was found that the shock impedance increased from 40 ohms to 60 ohms and then to greater than 200 ohms.No sources of electromagnetic interference (emi) could be identified.The patient was seen again three weeks later where the increase in ra lead impedance measurements were able to be recreated with pocket manipulation.It was noted when reprogrammed from triad to rv coil to can there were no high shock impedance measurements.It was further noted that another manufacturer¿s left ventricular (lv) lead exhibited spikes in impedance measurements that were unable to be reproduced.The clinic noted that this had been occurring for some time and had been programmed rv to lv tip, a possible connection issue between the crt-d and lv lead spring contact was considered as a potential cause.This connection issue was also thought to be a potential cause for the ra lead noise and impedance changes.The high shock impedance measurements were thought to be caused by possible growth on the proximal coil or a lead fracture.The clinic note that the patient has not had any tachycardia therapy since the crt-d was implanted, thus they are considering downgrading the patient to a cardiac resynchronization therapy pacemaker (crt-p) device.At this time the clinic has opted to continue to monitor.

• 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: 7475933
• MDR Text Key: 107083686
• Report Number: 2124215-2018-07793
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534614
• UDI-Public: 00802526534614
• 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
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/05/2018
• Device Model Number: G150
• 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: 03/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2016
• 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: 64 YR