MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 3 IS-1; IMPLANTABLE LEAD

Model Number 4548

Device Problems Difficult to Remove (1528); Device Contamination with Chemical or Other Material (2944)

Patient Problems Endocarditis (1834); Staphylococcus Aureus (2058); No Code Available (3191); Pericardial Effusion (3271)

Event Date 11/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) patient experienced an infection and endocarditis.An echocardiogram was performed, and vegetation was seen on the leads.Subsequently, a revision procedure was performed.It was noted that during the beginning of the procedure there was a trace of a pericardial effusion, however, the pericardial space was monitored and there was no change during the entire procedure.The right ventricular (rv) lead fragmented during the removal process; however, the entire rv lead was successfully removed.The crt-p, left ventricular (lv) lead, non-boston scientific right atrial (ra) lead, and non-boston scientific rv lead were successfully explanted.No additional adverse patient effects were reported.

• Brand Name: EASYTRAK 3 IS-1
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; RQ 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 11234049
• MDR Text Key: 228838303
• Report Number: 2124215-2021-02320
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526420276
• UDI-Public: 00802526420276
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S032
• 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: 01/26/2021

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: 03/23/2012
• Device Model Number: 4548
• Device Catalogue Number: 4548
• Device Lot Number: 165322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 01/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2010
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR