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

Model Number	S401
Medical Device Problem Codes	Failure to Capture (1081); Use of Device Problem (1670); Capturing Problem (2891); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Enzyme Elevation (1838); Unspecified Infection (1930); Sepsis (2067)
Date of Event	04/18/2016
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 this product was part of a system revision due to infection.It was also reported that the patient had rhabdomyolysis and sepsis resulting to high pacing threshold measurements and loss of capture.Furthermore, the patient had elevated creatinine phosphokinase enzymes.This pacemaker was then used as an external temporary pacing device.There were no additional adverse patient effects reported.The product remains in service.
Event or Problem Description
Additional information received that the product was explanted when the new system was implanted.

• Brand Name: ALTRUA
• Common Device Name: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• MDR Report Key: 5800340
• Report Number: 2124215-2016-07951
• Device Sequence Number: 23047
• Product Code: LWP
• UDI-Device Identifier: 00802526484438
• UDI-Public: (01)00802526484438(17)20130407
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2016

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/07/2013
• Device Model Number: S401
• Other Device ID Number: ALTRUA 40
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2016
• Supplement Report FDA Received Date: 07/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR