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

Model Number	S401
Medical Device Problem Codes	High impedance (1291); Over-Sensing (1438); Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Boston scientific received information that the configuration on the right atrial (ra) lead switched to unipolar as a result of high out of range impedance measurements.While in unipolar configuration, there were a lot of episodes of oversensing.The configuration was reprogrammed to bipolar and minute ventilation (mv) was programmed on.After that, mv chop was observed.As a result, mv was programmed off and the noise was resolved.No further changes were made to the system.No 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.
Additional Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.
Event or Problem Description
Subsequent information was received that this device was explanted and returned.No additional adverse patient effects were reported.

• Brand Name: ALTRUA
• Common Device Name: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• MDR Report Key: 7981215
• Report Number: 2124215-2018-17032
• Device Sequence Number: 1584914
• Product Code: LWP
• UDI-Device Identifier: 00802526484438
• UDI-Public: (01)00802526484438(17)20131130
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2018

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2013
• Device Model Number: S401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 08/03/2018
• Supplement Date Received by Manufacturer: 11/07/2018; 11/20/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 11/14/2018; 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1194; 4470; S401
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR