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

Model Number 4517

Device Problems High impedance (1291); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/06/2018

Event Type  Injury  

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 Description

Boston scientific received information that an out-of-range impedance alert was issued for this left ventricular (lv) lead.Initially, the out-of-range measurement was not listed in device memory.Boston scientific technical services (ts) discussed it was likely that the 24-hour-period was still in progress.The patient conducted a patient initiated interrogation with a resulting lv impedance measurement of greater than 2500 ohms.It was noted that the patient had an upcoming device check scheduled.No adverse patient effects were reported.Thsi lead remains in service.

Event Description

This lead was surgically abandoned.No adverse patient effects were reported.

• 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: 7618520
• MDR Text Key: 111636393
• Report Number: 2124215-2018-10485
• 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: 11/01/2018

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/29/2006
• Device Model Number: 4517
• 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: 05/06/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 11/01/2018
• Supplement Dates FDA Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2004
• 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
• Treatment: 0185; 4269; 4517; 5024M; H175; MISMATCH; N118
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 81 YR