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

Model Number	S203
Medical Device Problem Codes	Failure to Capture (1081); Electrical /Electronic Property Problem (1198); High impedance (1291); Over-Sensing (1438); Failure to Sense (1559); Ambient Noise Problem (2877)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the device remains in service.If additional information is received, this report will be updated.
Event or Problem Description
Boston scientific received information that this implantable pacemaker exhibited high right atrial (ra) impedance measurements of greater than 2500 ohms, loss of capture, non-sensing, noise, oversensing and inappropriate atrial tachy response (atr) episodes.The patient was not ra lead dependent, and had an underlying rhythm in the 50 beats per minute (bpm) range.The lead was tested in bipolar configuration and similar values were obtained.The device was programmed ddd in unipolar configuration.No adverse patient effects were reported.The device remains in service.
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
Additional information was received which indicated that a surgical revision was performed.During the procedure, visual inspection of the patient's ra lead noted it appeared to be fractured at the suture line.High pacing threshold measurements were also noted.Additionally, there were episodes of rv noise and oversensing noted.The device was explanted and replaced due to normal battery depletion.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: 6707193
• Report Number: 2124215-2017-11009
• Device Sequence Number: 16294651
• Product Code: LWP
• UDI-Device Identifier: 00802526484391
• UDI-Public: (01)00802526484391(17)20140313
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2017

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: 03/13/2014
• Device Model Number: S203
• Other Device ID Number: ALTRUA 20
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 06/20/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 07/12/2017
• Supplement Report FDA Received Date: 01/17/2018
• 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: 4087; 4088; S203
• Patient Age: 75 YR