MAUDE Adverse Event Report: CPI - DEL CARIBE EASYTRAK 3; IMPLANTABLE LEAD

Model Number 4524

Device Problem Pocket Stimulation (1463)

Patient Problems Muscle Stimulation (1412); Heart Failure (2206)

Event Date 03/24/2004

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 the patient implanted with this left ventricular (lv) lead complained of muscle stimulation and lack of sleep.The lead has been electrically repositioned several times with limited success.The lead was electrically deactivated but the patient¿s heart failure worsened so the lead was programmed back on.The associated device is pending replacement for normal battery depletion.At that time the lv lead will be upgraded.No additional adverse patient effects were reported.

• Brand Name: EASYTRAK 3
• 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: 6929456
• MDR Text Key: 88954804
• Report Number: 2124215-2017-13191
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/19/2005
• Device Model Number: 4524
• Other Device ID Number: EASYTRAK 3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2004
• 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
• Patient Outcome(s): Required Intervention