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

Model Number 4518

Device Problems High impedance (1291); Pocket Stimulation (1463)

Patient Problems Muscle Stimulation (1412); Heart Failure (2206); No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2017

Event Type  malfunction  

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 this left ventricular (lv) lead has been exhibiting a gradual rise in pace impedances.The impedances then became high enough to be out of range at greater than 2500 ohms.This lv lead remains in service and the patient is being monitored.No adverse patient effects were reported.

Event Description

Additional information was received which indicated reprogramming was performed.However, the patient then felt stimulation.Adjustments were again made to reprogramming which resolved the stimulation.The lv pace impedances are stable.The lead remains in service and the patient is being monitored.No adverse patient effects were reported.

Event Description

Additional information was received which indicated this patient has repeatedly skipped their previous appointments and now presented due to heart failure symptoms.The system was checked and it was noted this patient's system was previously programmed to monitor only.Since the bi-ventricular pacing stopped, there have been right ventricular (rv) intrinsic amplitude alerts observed.At this time, the patient was evaluated further and it was determined the heart failure symptoms were due to the patient's atrial fibrillation.Reprogramming was performed to increase rv and lv outputs.The patient is not dependent.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: 6931588
• MDR Text Key: 89946794
• Report Number: 2124215-2017-14005
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2018

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: 02/23/2007
• Device Model Number: 4518
• 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: 08/02/2017
• Initial Date FDA Received: 10/09/2017
• Supplement Dates Manufacturer Received: 08/09/2017; 08/30/2018
• Supplement Dates FDA Received: 10/11/2017; 10/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2005
• 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: 82 YR