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

Model Number 4542

Device Problems Fracture (1260); High impedance (1291)

Patient Problems Dyspnea (1816); Heart Failure (2206)

Event Date 01/06/2017

Event Type  Injury  

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

Boston scientific received information that the patient was admitted to the hospital due to exacerbated heart failure symptoms including shortness of breath.Upon interrogation it was noted that the pacing rate spontaneously increased to 125 paces per minute and then went back down to the lower rate limit.The longest length of time the patient's heart rate was elevated at 125 ppm was 20 minutes.The post ventricular atrial refractory period was programmed out.A field representative was then contacted to interrogate the device and found high out of range pacing impedance measurements of greater than 2000 ohms.A fracture in the clavicle region was the suspected cause of the high impedance measurements.A revision procedure was performed where the device and lead were explanted.During the revision the fracture was able to be confirmed via fluoroscopy.The cause of the high rate pacing remained unknown.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, it was noted the lead was returned severed at 72 mm from the terminal pin and in two segments.Visual inspection noted dried blood and body fluid in the lead lumen along with electro cautery damage in the insulation.Analysis confirmed the cathode and anode conductor coils are fractured approximately 420-422mm from the terminal pin.Detailed analysis of the fracture site determined the conductor coil was fractured due to cyclic fatigue.The location of the damage site suggests the fracture was a result of stress due to the suture sleeve.There was a bend noted at this location and the inner insulation was torn as well.

• 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 ; 6515824786
• MDR Report Key: 6475546
• MDR Text Key: 72210042
• Report Number: 2124215-2017-01072
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410901
• UDI-Public: (01)00802526410901(17)20140810
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2017

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: 08/10/2014
• Device Model Number: 4542
• Other Device ID Number: EASYTRAK 2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/10/2017
• Initial Date FDA Received: 04/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2012
• 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: 0295; 0296; 4136; 4542; N140; N160
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 73 YR