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

Model Number 4538

Device Problems Failure to Capture (1081); Capturing Problem (2891)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/18/2018

Event Type  Injury  

Manufacturer Narrative

The lead remains surgically abandoned.If additional information is received, this report will be updated.

Event Description

Boston scientific received information that this left ventricular (lv) exhibited high threshold.Additional information indicates that this lead hadn't been working and the patient has been feeling tired even before device change out.This lead was also reported to exhibit loss of capture.The lead was surgically abandoned.No additional adverse patient effects were reported.

Event Description

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• Brand Name: EASYTRAK
• 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: 8199820
• MDR Text Key: 131512097
• Report Number: 2124215-2018-19484
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S010
• 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: 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: 11/20/2009
• Device Model Number: 4538
• 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: 12/27/2018
• Supplement Dates Manufacturer Received: 09/05/2018
• Supplement Dates FDA Received: 12/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2007
• 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: 0185; 4047; 4538; 4543; 4555; H217; MISMATCH; N119
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR