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

Model Number 4543

Device Problems Failure to Capture (1081); High impedance (1291); Ambient Noise Problem (2877)

Patient Problem Edema (1820)

Event Date 09/05/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Boston scientific received information that this left ventricular (lv) lead exhibited impedance measurements of greater than 2500 ohms and loss of capture.The patient was noted to have fluid accumulation and ascites.The lead was assessed, and the vector was changed with good lead measurements.The reprogramming resolved the issues.Then intermittent baseline noise was noted on the lv channel in the new vector, which appeared to look like minute ventilation (mv) oversensing; therefore, the mv feature was programmed off.No 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: 7984333
• MDR Text Key: 124317712
• Report Number: 2124215-2018-18719
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410994
• UDI-Public: (01)00802526410994(17)20150814
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/05/2018

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: 08/14/2015
• Device Model Number: 4543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 09/05/2018
• Initial Date FDA Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2013
• 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
• Treatment: 0186; 4136; 4543; N161; T180
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 74 YR