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

Model Number 4518

Device Problems Over-Sensing (1438); Pacing Problem (1439)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

At this time, the lead remains in service.If additional information is received, this report will be updated.

Event Description

Boston scientific received information that this left ventricular (lv) lead exhibited oversensing of atrial signals, which caused inhibition of lv pacing.The patient did not feel well due to the loss of lv pacing.The lv lead measurements were stable.Troubleshooting and programming options were discussed.No additional adverse patient effects were reported.The lead remains in service.

Event Description

Additional information was received which noted that no troubleshooting was performed.A subsequent remote routine check showed 100% biventricular pacing.The patient would continue to be followed.No additional adverse patient effects were reported.The lead remains in service.

• 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: 7630887
• MDR Text Key: 112078717
• Report Number: 2124215-2018-11089
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

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: 08/02/2008
• Device Model Number: 4518
• Other Device ID Number: EASYTRAK 2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/15/2018
• Initial Date FDA Received: 06/22/2018
• Supplement Dates Manufacturer Received: 06/21/2018
• Supplement Dates FDA Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2006
• 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: 0181; 4086; 4518; H219; N164
• Patient Outcome(s): Life Threatening
• Patient Age: 77 YR