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); Capturing Problem (2891)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) and left ventricular (lv) lead exhibited a high out of range pacing impedance measurement greater than 2,000 ohms.Subsequent measurements were noted to be 1,000 to 1,900 ohms.Boston scientific technical services (ts) discussed troubleshooting options.No adverse patient effects were reported.This product remains implanted and in service.
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
Additional information was received that the patient was seen in clinic one week later.No additional high out of range pacing impedance measurements were observed, however, lv pacing impedance measurements were noted to have doubled to 2.2 volts and resulted in intermittent capture.The programmed lead configuration was changed to ring to rv and threshold measurements of 1.5 volts was observed.Lv outputs were increased to 3.0 volts and monitoring will be continued.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: 6707730
• Report Number: 2124215-2017-11527
• Device Sequence Number: 11052136
• Product Code: NIK
• UDI-Device Identifier: 00802526579813
• UDI-Public: (01)00802526579813(17)20170317
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2017

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: 03/17/2017
• Device Model Number: 4543
• Other Device ID Number: EASYTRAK 2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 07/03/2017
• Initial Report FDA Received Date: 07/12/2017
• Supplement Report FDA Received Date: 10/11/2017
• 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: 78 YR