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

Model Number 4543

Device Problems Device Alarm System (1012); High impedance (1291); Ambient Noise Problem (2877); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/18/2018

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 one instance of a high, out-of-range pacing impedanceon this left ventricular (lv) lead led to the associated device issuing an alert and emitting beep tones.Ts discussed bringing the patient in to the clinic to clear the alert, evaluate for noise, and check thresholds.The patient was seen in clinic and the beeping for an out-of-range lv impedance measurement was turned off.This lead remains in service.No adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this lead was confirmed to be fractured approximately 4.4 cm from the terminal pin.The insulation in this area was abraded.Based on the analysis results, we suspect that fatigue or stress in the region of the fracture site due to relative motion between the suture sleeve and an anatomical feature led to the fracture.As a lead moves in response to normal heart rhythms and blood flow, extensive flexing over a period of time may cause fatigue or stress, weakening the coil, ultimately resulting in a fracture.This can occur between the suture sleeve and some other part of the anatomy.A combination of lead design, implant techniques, and patient anatomy and activity level contribute to these types of occurrences.

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

Event Description

Additional information was received indicating that the physician believed that the lead was fractured.

Event Description

Additional information was received indicating that the associated lv lead was still capturing, but thresholds were inconsistent.Further information was received indicating that re-create noise was noted on the lv channel.It was reported that a lead revision would be scheduled.

• 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: 7696306
• MDR Text Key: 114278938
• Report Number: 2124215-2018-12503
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410994
• UDI-Public: 00802526410994
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/27/2018

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: 09/10/2015
• Device Model Number: 4543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 07/17/2018
• Supplement Dates Manufacturer Received: 09/13/2018; 10/09/2018; 11/27/2018
• Supplement Dates FDA Received: 10/18/2018; 11/14/2018; 12/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2013
• 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: 76 YR