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

Model Number	S205
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.
Event or Problem Description
Boston scientific received information that the patient with this pacemaker and right atrial (ra) and right ventricular (rv) leads from another manufacturer exhibited noise and oversensing leading to pacing inhibition.The noise was able to be reproduced with isometrics.Boston scientific technical services (ts) discussed decreasing sensitivity in the atrium and ventricle to increase pacing.The system was abandoned and a new system was implanted in the right side.The device was later explanted.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 a cored out hole in the right ventricular seal plug.The device was then exposed to simulated heart load conditions, and the right ventricular pacing and sensing functions were tested.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.Laboratory analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

• Brand Name: ALTRUA
• Common Device Name: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• MDR Report Key: 6021733
• Report Number: 2124215-2016-15048
• Device Sequence Number: 10872998
• Product Code: LWP
• UDI-Device Identifier: 00802526499210
• UDI-Public: (01)00802526499210(17)20160929
• Combination Product (Y/N): N
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2016

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: 09/29/2016
• Device Model Number: S205
• Other Device ID Number: ALTRUA 20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2016
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2016
• Supplement Report FDA Received Date: 10/14/2016
• 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: 5357; 6957; 6957J; S205
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 70 YR