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

Model Number G146

Device Problems Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2018

Event Type  Injury  

Manufacturer Narrative

The device remains in service at this time.If additional information is received, this report will be updated.

Event Description

Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) exhibited right ventricular (rv) noise on the rate/sense and shock channels.The noise was oversensed and caused pacing inhibition with a four second pause.The noise was reproducible on the shock channel.The rv pacing and shock impedance measurements were stable.Additional information was received which noted that there was also right atrial (ra) noise, and that the noise on all three channels was likely caused by electromagnetic interference (emi).This device remains in service.No adverse patient effects were reported.

Event Description

Additional information was received which noted that the rv sensitivity was reprogrammed due to the noise and oversensing.This resolved the noise; therefore, the patient would continue to be monitored.No additional adverse patient effects were reported.The device remains in service.

• Brand Name: INOGEN
• 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: 7761090
• MDR Text Key: 116360558
• Report Number: 2124215-2018-15218
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534577
• UDI-Public: 00802526534577
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/23/2017
• Device Model Number: G146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2015
• 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: 0185; 4469; E143; G146; MISMATCH
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR