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

Model Number	4543
Medical Device Problem Codes	Failure to Capture (1081); High impedance (1291); Extracardiac stimulation (1463); Use of Device Problem (1670)
Health Effect - Clinical Code	Muscle Stimulation (1412)
Date of Event	10/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the product remains in-service.If additional information is received, this report will be updated.
Event or Problem Description
Boston scientific received information that this left ventricular (lv) lead was plugged into the right atrial (ra) port.During implant one month ago, the initial location of the lv lead had stimulation and loss of capture.The lead was repositioned prior to wound closure, where the final location had impedance values of 1890 ohms.The lv lead had now triggered a lead safety switch, as there was high out of range impedance values greater than 2000 ohms.The lead was in unipolar, and the plan was to increase the out of range limit to 3000 ohms.Lead remains in service.No 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: 7194069
• Report Number: 2124215-2017-22041
• Device Sequence Number: 723046
• Product Code: NIK
• UDI-Device Identifier: 00802526579813
• UDI-Public: 00802526579813
• Combination Product (Y/N): N
• PMA/510(K) Number: P010012/S024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/09/2019
• Device Model Number: 4543
• 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: 11/14/2017
• Initial Report FDA Received Date: 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR