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

Model Number 4518

Device Problem High impedance (1291)

Patient Problems Congestive Heart Failure (1783); Complete Heart Block (2627); No Known Impact Or Consequence To Patient (2692)

Event Date 04/20/2016

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested.This report will be updated should further information be received.

Event Description

Boston scientific received information that this device and leads exhibited high out-of-range left ventricular (lv) pace impedance and out-of-range right atrial (ra) lead and right ventricular (rv) lead amplitude measurements.A health care professional (hcp) contacted boston scientific technical services (ts) to ask why there was no alert for shock therapy on the date it was delivered.Upon reviewing remote monitoring data, ts discussed that the episode spanned a few days and the shock was captured as part of an electrogram that began recording the day prior.While reviewing the remote monitoring data, ts noted the aforementioned out-of-range measurements.This lv lead remains in service.No adverse patient effects were reported.

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

Additional information received indicates that the left ventricular (lv) pace impedance measurements were elevated, but were within safety margins.The clinician indicated the root cause of the observed out-of-range amplitude measurements were likely due to patient's conditions, including complete heart block, congestive heart failure, and paroxysmal atrial fibrillation.At this time, the clinic plans to continue close monitoring of this patient.No surgical intervention is planned at this time.This product remains in service.No 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5790263
• MDR Text Key: 49412961
• Report Number: 2124215-2016-08684
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526417672
• UDI-Public: (01)00802526417672(17)20101205
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/05/2010
• Device Model Number: 4518
• 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: 05/16/2016
• Initial Date FDA Received: 07/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2008
• 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: (B)(4)
• Patient Age: 80 YR