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

Model Number 4543

Device Problems Failure to Capture (1081); Fracture (1260); Migration or Expulsion of Device (1395); Pacing Problem (1439); Material Integrity Problem (2978)

Patient Problems Cardiomyopathy (1764); No Consequences Or Impact To Patient (2199); Heart Failure (2206)

Event Date 03/26/2014

Event Type  Injury  

Event Description

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Manufacturer Narrative

(b)(4).Upon receipt at our post market quality assurance laboratory, a complete lead was returned.Analysis reveals all coils fractured approximately 41 cm from the terminal pin, possibly a suture sleeve tie-down location.

Event Description

Boston scientific received information that this left ventricular (lv) lead exhibited loss of capture (loc) and pacing therapy was not delivered when it was required.Additional information was received indicating that the lead sustained damage to the insulation, lead body and conductor coils.The fracture to the conductors was confirmed via chest x-ray.The lead was explanted and replaced.No additional 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.

• 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: sharon zurn ; 4100 hamline ave. n; st. paul, MN 55112 ; 6515824786
• MDR Report Key: 3760894
• MDR Text Key: 4516524
• Report Number: 2124215-2014-08764
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• 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: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/26/2014
• Device Model Number: 4543
• Other Device ID Number: EASYTRAK 2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2012
• 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; 4470; N140; 4543
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR