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

Model Number	4458
Medical Device Problem Codes	Fracture (1260); High impedance (1291); Over-Sensing (1438); Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2016
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 lead and associated device triggered a lead safety switch for out of range impedances.The system also displayed noise and oversensing.Isometrics were performed where noise was able to be elicited.The system will continue to be monitored.There were no adverse patient effects reported.
Event or Problem Description
Subsequent information indicates that the patient underwent a surgical revision procedure.It was also reported that the lead was suspected to have fractured.The lead was surgically abandoned; the device was explanted.There were no additional adverse patient effects 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: 5840162
• Report Number: 2124215-2016-12279
• Device Sequence Number: 692542
• Product Code: DTB
• UDI-Device Identifier: 00802526060953
• UDI-Public: (01)00802526060953(17)20120310
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 02/14/2017

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: 03/10/2012
• 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): FDA Requested
• Initial Date Received by Manufacturer: 05/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2016
• Supplement Report FDA Received Date: 04/13/2017
• 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: 74 YR