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 Patient Problem/Medical Problem (2688)

Event Date 04/18/2018

Event Type  Injury  

Manufacturer Narrative

No additional information is available.If additional information becomes available the report will be updated at that time.

Event Description

Boston scientific received information that while the patient was hospitalized for a non-cardiac reason, it was noted that the cardiac resynchronization therapy defibrillator (crt-d) and right ventricular (rv) lead stored three episodes of oversensing noise that led to pacing inhibition with asystole ranging from just over two seconds to six seconds.The rate response trend feature was programmed off in the crt-d.Boston scientific technical services (ts) was consulted and discussed further troubleshooting and programming options.It was noted that the patient had an occlusion, thus the previous upgrade to the bi-ventricular device was difficult and the patient was very sick.The cause of the noise was not able to be determined.The field representative stated that the physician was considering programming electrocautery mode while the patient was in the hospital.Ts advised that the patient would not have tachycardia therapy available with that programming.The field representative stated that no further tests were performed and the physician elected to program electrocautery mode on.The patient was discharged from the hospital with a life vest until a decision was made on how to proceed.The field representative is unaware if any other changes have been made to the system or if the patient has been seen since being discharged.The crt-d and rv lead remain in service and no additional adverse patient effects were reported.

• 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: 7616308
• MDR Text Key: 111611933
• Report Number: 2124215-2018-09657
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534577
• UDI-Public: 00802526534577
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• 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: 04/18/2018

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/24/2017
• Device Model Number: G146
• Other Device ID Number: INOGEN X4 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: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2015
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 61 YR