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

Model Number	4458
Medical Device Problem Codes	Fracture (1260); High impedance (1291); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.
Event or Problem Description
Boston scientific received information that this right ventricular (rv) lead exhibited high out of range pace impedance measurements and a drop in sensing.Clavicular crush of the lead was suspected, and at the lead revision procedure it was found that the lead was completely fractured.The lead was partially capped and abandoned and the proximal portion was returned for analysis.A new rv lead was successfully implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.The anode and cathode conductor coils were found to be fractured approximately 196 millimeters (mm) from the terminal pin, and the insulation was found to be damaged approximately 192-196mm from the terminal pin.Due to the location and type of damage, it was concluded that it was likely caused by entrapment in the clavicle/first-rib region.

• 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: 5795488
• Report Number: 2124215-2016-10397
• Device Sequence Number: 556494
• Product Code: DTB
• UDI-Device Identifier: 00802526060953
• UDI-Public: (01)00802526060953(17)20170515
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2016

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: 05/15/2017
• Device Model Number: 4458
• Other Device ID Number: FINELINE II STEROX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/14/2016
• 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: Life Threatening; Required Intervention
• Patient Age: 79 YR