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

Model Number	S203
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2017
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 during threshold testing the field representative was unable to obtain capture when programmed to pace and sense in the ventricle only.When programmed to pace and sense in both chambers, capture was obtained.It was noted that the pacemaker was programmed to pace and sense in both chambers and continued to be programmed this way.This issue occurred at two different follow up visits.An x-ray was taken, however the cause remained unknown.At this time the pacemaker and right ventricular (rv) lead remain in service and no 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: 6480873
• Report Number: 2124215-2017-04597
• Device Sequence Number: 850125
• Product Code: LWP
• UDI-Device Identifier: 00802526484391
• UDI-Public: (01)00802526484391(17)20130608
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 02/24/2017

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: 06/08/2013
• Device Model Number: S203
• Other Device ID Number: ALTRUA 20
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2017
• Initial Report FDA Received Date: 04/11/2017
• 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: 4135; 4136; S203
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR