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

Model Number G146

Device Problems Premature Discharge of Battery (1057); Defibrillation/Stimulation Problem (1573); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem Angina (1710)

Event Date 05/18/2018

Event Type  Injury  

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

Event Description

Boston scientific received information that there was an alert on this cardiac resynchronization therapy defibrillator (crt-d) related to the right ventricular (rv) lead that is connected to the crt-d.The rv lead is another manufacturer's lead.A code 1004 alert was triggered, as a short circuit was detected.Additionally a code 1007 was triggered indicating that the charge time exceeded 45 seconds, as the charge could not complete.Additional information was reported indicating that on the same day, the battery capacity had depleted, after being implanted for 3 years.The device was operating only in the rv, pacing at 50 paces per minute and therapy was only available in the ventricular fibrillation (vf) zone at 165 beats per minute (bpm).The patient was admitted as they were complaining of chest pain.A few days later, the device failed to detect vf and a shock was externally delivered.The device was subsequently removed and replaced and the leads were surgically abandoned.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a visual inspection of the device noted no anomalies on the titanium case.Review of the stored memory confirmed a shorted lead indicator and 2 charge time indicators were recorded by the device.A real time x-ray noted that the plasma fuse has been blown open.Based on inspection and analysis of this device, evidence indicates the device was damaged after delivering a shock through a shorted defibrillation lead.The clinical observations occurred as a result of the shorted lead.The lead is from another manufacturer.

• 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: 7662648
• MDR Text Key: 113149307
• Report Number: 2124215-2018-11984
• 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,Followup
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/24/2016
• Device Model Number: G146
• Other Device ID Number: INOGEN X4 CRT-D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2014
• 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; Required Intervention
• Patient Age: 72 YR