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

Model Number G148

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

Patient Problem Complete Heart Block (2627)

Event Date 03/22/2017

Event Type  Injury  

Manufacturer Narrative

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 following implant of this system, a review of telemetry strips noted three seconds pauses in pacing which resulted in asystole for this patient.A boston scientific technical services consultant reviewed the electrograms and discussed the resemblance to crosstalk from the atrial paced events on the right ventricular (rv) channel.The consultant confirmed the signal is not being oversensed in most complexes.The boston scientific sales representative stated an x-ray and all lead measurements were stable and consistent with implant numbers.The physician kept the patient an extra night in the hospital for observation.System evaluation the following day showed the clinical observations were still occurring intermittently and the physician suspects it is due to the proximity of the rv coil to a valve.Reprogramming was performed and the patient was going to be seen again for defibrillation threshold testing (dft).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 ; 6515824786
• MDR Report Key: 6504144
• MDR Text Key: 73218707
• Report Number: 2124215-2017-06241
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: (01)00802526534591(17)20180927
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/27/2018
• Device Model Number: G148
• Other Device ID Number: INOGEN X4 CRT-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/23/2017
• Initial Date FDA Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2016
• 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: 0275; 4671; 7740; G148
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 77 YR