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

Model Number 4543

Device Problems High impedance (1291); Capturing Problem (2891)

Patient Problems Atrial Tachycardia (1731); Complaint, Ill-Defined (2331)

Event Date 08/10/2017

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested regarding this event.Should additional information be received, this event will be updated.

Event Description

Boston scientific received information that this left ventricular (lv) lead exhibited high impedance measurements of greater than 2500 ohms, and threshold measurements had been increasing.The patient¿s health was noted to have been deteriorating; therefore, no actions were going to be taken.No adverse patient effects were reported.The lead remains in service.

Manufacturer Narrative

At this time, the lead remains in service.If additional information is received, this report will be updated.

Event Description

Additional information was received which noted that no further troubleshooting was performed.The patient's health was deteriorating due to multi-system organ failure, which was unrelated to the device system.No adverse patient effects were reported.The lead remains in service.

• Brand Name: EASYTRAK 2
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 6932150
• MDR Text Key: 89973329
• Report Number: 2124215-2017-14901
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2017

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/16/2007
• Device Model Number: 4543
• Other Device ID Number: EASYTRAK 2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/10/2017
• Initial Date FDA Received: 10/09/2017
• Supplement Dates Manufacturer Received: 08/31/2017
• Supplement Dates FDA Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR