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

Model Number G156

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

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

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

The local area field representative was contacted for additional information.It was reported the patient was brought into clinic for evaluation.Noise was unable to be recreated and impedance measurements remain stable.The respiratory sensor was programmed off to mitigate further oversensing on the atrial channel.The system will continue to be monitored.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 cardiac resynchronization therapy defibrillator (crt-d), implanted with another manufacturer's leads, recorded inappropriate atrial tachy response episodes due to oversensing of the respiratory sensor.Baseline noise was also noted on the right ventricular channel which appeared to be myopotential.This noise was not being sensed by the device.A spike in the right ventricular pacing impedances had been observed.Boston scientific technical services (ts) discussed possible causes and provided troubleshooting options.No 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: 7755802
• MDR Text Key: 116221041
• Report Number: 2124215-2018-14742
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/07/2018

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: 01/28/2018
• Device Model Number: G156
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2016
• 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
• Treatment: 4674; 5076; 6947; D154AWG; G156
• Patient Age: 69 YR