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

Model Number	4542
Medical Device Problem Codes	Over-Sensing (1438); Under-Sensing (1661)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Non specific EKG/ECG Changes (1817); High Blood Pressure/ Hypertension (1908); Dizziness (2194)
Date of Event	12/27/2016
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 patient presented to the emergency room due to hypertension, dizziness and worsening heart failure.Upon device review, it was found the patient went into atrial fibrillation.The device also was found to have exhibited undersensing and oversensing was observed on the left ventricular (lv) channel.The lv lead was surgically abandoned.No additional adverse patient effects were reported.

• 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: 6475313
• Report Number: 2124215-2017-01639
• Device Sequence Number: 18915469
• Product Code: NIK
• UDI-Device Identifier: 00802526579806
• UDI-Public: (01)00802526579806(17)20170522
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/05/2017

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: 05/22/2017
• Device Model Number: 4542
• Other Device ID Number: EASYTRAK 2
• 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: 01/05/2017
• Initial Report FDA Received Date: 04/10/2017
• 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: 0293; 4136; 4542; G150
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 61 YR