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

Model Number	S203
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was abandoned on the patient's left side.The source of the reported clinical observations was not identified as the system was abandoned on the patient's left side.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 this pacemaker dependent patient was having pauses via telemetry.A boston scientific sales representative was called to evaluate the system and no pauses were identified.There was some slight noise and oversensing on the right ventricular (rv) channel on some of the patient's electrocardiograms.Isometrics and device manipulation were performed and no inhibition was observed.The rv output and sensitivity were reprogrammed.Later that day, the physician again noted noise, oversensing and pacing inhibition with some intermittent capture.The following day, a revision procedure was performed to replace the lead.The associated device was close to elective replacement indicator (eri) and the physician wanted to also replace the device.Access to the left side could not be obtained and a new system was implanted on the patient's right side.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: 6021228
• Report Number: 2124215-2016-13796
• Device Sequence Number: 441409
• Product Code: LWP
• UDI-Device Identifier: 00802526484391
• UDI-Public: (01)00802526484391(17)20130120
• Combination Product (Y/N): N
• 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): 07/29/2016

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: 01/20/2013
• 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: 07/29/2016
• Initial Report FDA Received Date: 10/12/2016
• 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: 1296; 4472; 4473; 7740; 7741; L101; S203
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention