MAUDE Adverse Event Report: CPI - DEL CARIBE EASYTRAK 2; IMPLANTABLE LEAD

Model Number	4543
Medical Device Problem Codes	Fracture (1260); High impedance (1291); Capturing Problem (2891)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2017
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 left ventricular (lv) lead had observations of high pacing thresholds and out of range high pacing impedances greater than 2000 ohms.The lead was explanted and replaced, where it was observed that the lead was fractured.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this lead was confirmed to be fractured 35.8 cm from the terminal pin.Based on the analysis results, we suspect that fatigue or stress in the region of the fracture site due to relative motion between the suture sleeve and an anatomical feature led to the fracture.As a lead moves in response to normal heart rhythms and blood flow, extensive flexing over a period of time may cause fatigue or stress, weakening the coil, ultimately resulting in a fracture.This can occur between the suture sleeve and some other part of the anatomy.Fatigue fractures in the pocket or clavicular/first rib area are well known and documented in the industry.A combination of lead design, implant techniques, and patient anatomy and activity level contribute to these types of occurrences.Laboratory analysis confirms that the allegations of high impedance and thresholds were likely due to the conductor damage in the area of the suture sleeve tie-down.

• Brand Name: EASYTRAK 2
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• MDR Report Key: 7411156
• Report Number: 2124215-2018-05856
• Device Sequence Number: 1236163
• Product Code: NIK
• UDI-Device Identifier: 00802526579813
• UDI-Public: 00802526579813
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2018

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: 08/03/2017
• Device Model Number: 4543
• Other Device ID Number: EASYTRAK 2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 06/21/2018
• 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: 4087; 4470; 4543; V273
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR