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

Model Number 4517

Device Problems Failure to Capture (1081); Capturing Problem (2891)

Patient Problems Dyspnea (1816); Pulmonary Edema (2020); No Consequences Or Impact To Patient (2199); Heart Failure (2206)

Event Date 05/16/2017

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 left ventricular (lv) lead exhibited loss of capture (loc) due to increased/high pacing threshold measurements.The device was reprogrammed with high lv output and the patient scheduled for additional follow-up in several months time to review battery status and lead threshold.No adverse patient effects were reported.This system remains in service.

Event Description

Additional information was received that this patient presented to the clinic with dyspnea.Upon review, it was determined that the patient was in decompensated heart failure with severe pulmonary edema.The left ventricular (lv) pacing threshold was found to be increased beyond the programmed outputs.It was unknown how long the lv lead loss of capture had been occurring but the physician believed that it may have contributed to the patient's worsening heart failure.The lv output was increased and the physician discussed the potential need to replace the lv lead at the time of the next generator change.

• 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: 6703374
• MDR Text Key: 79727787
• Report Number: 2124215-2017-09382
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2006
• Device Model Number: 4517
• 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: 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2004
• 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): Hospitalization; Required Intervention