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

Model Number 4543

Device Problems Failure to Capture (1081); High impedance (1291)

Patient Problems Cardiomyopathy (1764); Ventricular Tachycardia (2132); Heart Failure (2206); Complete Heart Block (2627); No Known Impact Or Consequence To Patient (2692)

Event Date 05/02/2018

Event Type  Injury  

Manufacturer Narrative

The root cause of the reported clinical observations was not identified and efforts to obtain additional product issue details were unsuccessful.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 system exhibited pacing impedance measurements greater than 2000 ohms and no capture on the left ventricular (lv) channel.A revision procedure was performed and this lead and the associated device were removed from service and replaced.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 ; 6515826168
• MDR Report Key: 7631004
• MDR Text Key: 112085115
• Report Number: 2124215-2018-11125
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

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: 11/08/2008
• Device Model Number: 4543
• 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: 05/02/2018
• Initial Date FDA Received: 06/22/2018
• Supplement Dates Manufacturer Received: 07/03/2018
• Supplement Dates FDA Received: 11/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2006
• 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: 0154; 1861; 4469; 4543; 4549; 4674; G146; H217; N141
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR