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

Model Number 4525

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pneumothorax (2012)

Event Date 02/05/2016

Event Type  Injury  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Resistance and pressure tests were completed to assess lead electrical performance and insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.

Event Description

Boston scientific received information that during an attempt to implant an implantable cardioverter defibrillator (icd) lead, this left ventricular (lv) lead pulled back and caused the patient's blood pressure to drop.It was then determined that the patient developed pneumothorax as confirmed thru x-ray imaging.The health care professional (hcp) opted to close the pocket and will have a new system implanted on a later date as the patient recovers.This lead was never in service.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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5606874
• MDR Text Key: 43596997
• Report Number: 2124215-2016-06274
• 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: Physician
• Type of Report: Initial
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2017
• Device Model Number: 4525
• Other Device ID Number: EASYTRAK 3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2015
• 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: 0184
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 82 YR