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

Model Number G150

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Ventricular Fibrillation (2130); Heart Failure (2206)

Event Date 07/07/2017

Event Type  Injury  

Manufacturer Narrative

The crt-d will be returned.Once the product is received and laboratory analysis is completed, this report will be updated.

Event Description

Boston scientific received information that the patient with this cardiac resynchronization therapy defibrillator (crt-d) was hospitalized for worsening heart failure.The device was interrogated and everything appeared normal.Several days later, the patient experienced a ventricular fibrillation (vf) which was treated appropriately with shock therapy.The crt-d was interrogated again and revealed that it was in safety mode with limited therapy available.It was also noted that several additional alerts were recorded.Boston scientific technical services (ts) was contacted and replacement was recommended.A revision procedure was performed.The crt-d was successfully explanted and replaced.The right ventricular defibrillation lead was capped, surgically abandoned, and successfully replaced as well.No defibrillation testing was performed due to their worsening heart failure.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the crt-d was performed.A visual inspection noted tool marks on the case and header but no other anomalies.The crt-d was interrogated and was confirmed to be in safety mode.A review of the memory also noted the crt-d had exhibited multiple left ventricular runaway pacing alerts.Upon programming the crt-d back into primary operation mode, detailed analysis determined the cause of the crt-d entering safety mode was due to a programming and timing interaction with the patient¿s arrhythmia.There was no involvement in this particular issue by the right ventricular lead.

• 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: 6928621
• MDR Text Key: 88977893
• Report Number: 2124215-2017-12847
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/29/2015
• Device Model Number: G150
• Other Device ID Number: DYNAGEN CRT-D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2013
• 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): Hospitalization; Life Threatening