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

Model Number	S403
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of today, no additional information has been received.Should additional information be received or the device returned and analysis completed, this report will be updated.
Event or Problem Description
Boston scientific received information that this device and right ventricular (rv) lead displayed high pacing impedance measurements.The patient was seen for a revision procedure where the lead was was surgically abandoned and the device was explanted.A request for additional information and return of the device was made.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: 5816220
• Report Number: 2124215-2016-11502
• Device Sequence Number: 1076798
• Product Code: LWP
• UDI-Device Identifier: 00802526484445
• UDI-Public: (01)00802526484445(17)20130616
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 05/11/2016

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: 06/16/2013
• Device Model Number: S403
• Other Device ID Number: ALTRUA 40
• 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: 05/11/2016
• Initial Report FDA Received Date: 07/22/2016
• 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: 4135
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention