MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND ACCOLADE; IMPLANTABLE PULSE GENERATOR

Model Number	U226
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device remains in service at this time.If additional information is received, this report will be updated.
Event or Problem Description
Boston scientific received information that this cardiac resynchronization therapy pacemaker (crt-p) and a non-boston scientific right atrial (ra) lead exhibited impedance measurements of greater than 2500 ohms.The respiratory rate trend (rrt) was programmed off, and the device was left programmed to unipolar configuration.No adverse patient effects were reported.The device remains in service.
Additional Manufacturer Narrative
The device has been returned for analysis.This report will be updated upon completion of analysis.
Event or Problem Description
Additional information was received which indicated the device was explanted and replaced to upgrade the patient's therapy.No additional adverse patient effects were reported.
Additional 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.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.Impedance testing was completed and all measurements were within normal limits.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.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

• Brand Name: ACCOLADE
• Common Device Name: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• MDR Report Key: 7977310
• Report Number: 2124215-2018-15317
• Device Sequence Number: 1433693
• Product Code: LWP
• UDI-Device Identifier: 00802526559457
• UDI-Public: (01)00802526559457(17)20190109
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/09/2019
• Device Model Number: U226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 09/14/2018; 09/14/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 10/18/2018; 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR