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

Model Number 4542

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

Patient Problem Congestive Heart Failure (1783)

Event Date 07/28/2017

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 this cardiac resynchronization therapy defibrillator (crt-d) and left ventricular (lv) lead exhibited loss of capture (loc) and high out of range pacing impedance measurements greater than 2,000 ohms in the lv tip to ring configuration.The patient suffered from worsening congestive heart failure (chf) symptoms and was hospitalized.The configuration was changed to lv tip to can and appropriate sensing, threshold measurements, capture and in range pacing impedance measurements of 387 ohms was observed.It was unknown if the loc resulted in the worsening chf.The physician will continue monitoring.No additional adverse patient effects were reported.

Event Description

Additional information was received that during device and lead replacement, the lead was tested on a pacing system analyzer (psa) and also noted high out of range pacing impedance measurements.Lead to device header connections were verified to be appropriate.

Manufacturer Narrative

The lead was surgically abandoned and is not expected to be returned.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

Additional information was received that continued high out of range pacing impedance measurements were observed.An invasive procedure was performed.The device was explanted and replaced and the lead was surgically abandoned 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: 6931036
• MDR Text Key: 88953051
• Report Number: 2124215-2017-15523
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410901
• UDI-Public: 00802526410901
• 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,Followup,Followup
• Report Date: 12/22/2017

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: 04/01/2011
• Device Model Number: 4542
• 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
• Date Manufacturer Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2009
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR