MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 3; IMPLANTABLE LEAD

Model Number	4524
Medical Device Problem Code	High Capture Threshold (3266)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lead was surgically abandoned and replaced.As the lead will not be returned for analysis, the clinical observations cannot be confirmed.
Event or Problem Description
Boston scientific received information that this left ventricular (lv) lead was surgically abandoned due to high pacing thresholds.Additional information indicated that the cause for high threshold was unconfirmed as lead insulation looked normal and x-ray did not show any abnormalities.This lv lead is no longer in service.No additional adverse patient effects were reported.

• Brand Name: EASYTRAK 3
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8000188
• Report Number: 2124215-2018-60149
• Device Sequence Number: 1658791
• Product Code: NIK
• UDI-Device Identifier: 00802526353758
• UDI-Public: 802526353758
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2018

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: 03/30/2006
• Device Model Number: 4524
• Device Catalogue Number: 4524
• Device Lot Number: 156138
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 10/24/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR