MAUDE Adverse Event Report: CPI - DEL CARIBE FINELINE II; IMPLANTABLE LEAD

Model Number	4458
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Sepsis (2067)
Date of Event	11/04/2016
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 right ventricular (rv) lead was involved in a case of infection and sepsis.It was reported that vegetation was found on the patient's mitral valve, but not on the leads.The entire system was explanted.No additional adverse patient effects were reported.

• Brand Name: FINELINE II
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• MDR Report Key: 6261547
• Report Number: 2124215-2016-18893
• Device Sequence Number: 496965
• Product Code: DTB
• UDI-Device Identifier: 00802526060953
• UDI-Public: (01)00802526060953(17)20100813
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P960004/S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2016

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: 08/13/2010
• Device Model Number: 4458
• Other Device ID Number: FINELINE II STEROX
• 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: 11/04/2016
• Initial Report FDA Received Date: 01/18/2017
• 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: 4086; 4458; S203
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR