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

Model Number 4542

Device Problems Fracture (1260); High impedance (1291)

Patient Problems Dyspnea (1816); Fatigue (1849); Heart Failure (2206)

Event Date 12/13/2016

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 was admitted to the hospital with heart failure symptoms of shortness of breath and fatigue.The following day the device was interrogated and high out of range left ventricular (lv) pacing impedances of greater than 2500 ohms was noted in all configurations.An x-ray was taken of the lv lead which showed a fracture just distal to the suture sleeve.Further review found that there was a high out of range pacing impedance measurement alert stored in the remote home monitoring system from over three weeks earlier which had not been noticed by the clinic.At this time no revision has been scheduled due to the patient's age and other comorbidities.

Event Description

Additional information was received that the left ventricular (lv) lead was surgically abandoned due to the fracture.No additional 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 ; 6515824786
• MDR Report Key: 6475328
• MDR Text Key: 72230057
• Report Number: 2124215-2017-01013
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 04/13/2017

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/21/2007
• Device Model Number: 4542
• Other Device ID Number: EASYTRAK 2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/05/2017
• Initial Date FDA Received: 04/10/2017
• Supplement Dates Manufacturer Received: 04/13/2017
• Supplement Dates FDA Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2005
• 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
• Treatment: 0157; 1861; 4087; 4542; H210; N119
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 87 YR