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

Model Number W172

Device Problems Over-Sensing (1438); Pacing Problem (1439); Device Sensing Problem (2917); Material Integrity Problem (2978)

Patient Problem Syncope (1610)

Event Date 01/30/2014

Event Type  Injury  

Event Description

Boston scientific received information that the patient implanted with this cardiac resynchronization therapy pacemaker (crt-p) experienced several syncopal episodes and was admitted to the hospital.Device interrogation revealed noise that was oversensed on the right atrial (ra), right ventricular (rv), and left ventricular (lv) leads, which resulted in pacing inhibition.A device header issue was suspected, and the device was explanted and replaced with a competitive device.Lead measurements were within normal limits at the explant procedure, so the chronic leads remain in service with the new device.A boston scientific technical services consultant reviewed electrograms showing the oversensed noise and determined the noise appeared consistent with myopotential oversensing.However, further device data and programmed settings would be required to conclusively determine a cause for the noise.No additional adverse patient effects were reported.

Event Description

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Manufacturer Narrative

The explanted device is expected to be returned for laboratory analysis.This report will be updated upon return and completion of analysis.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.A visual inspection of the device header and case noted no anomalies.All seal plugs were intact and all setscrews moved freely.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the pacing and sensing functions were tested.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Laboratory analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations of noise and pacing inhibition.

• Brand Name: INGENIO
• 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: sharon zurn ; 4100 hamline ave. n; st. paul, MN 55112 ; 6515824786
• MDR Report Key: 3718024
• MDR Text Key: 4227681
• Report Number: 2124215-2014-03261
• Device Sequence Number: 1
• Product Code: NKE
• 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: 03/03/2014

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: 04/04/2015
• Device Model Number: W172
• Other Device ID Number: INVIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/03/2014
• Initial Date FDA Received: 04/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2013
• 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
• Treatment: W172; 4511
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention