MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 2 IS-1; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number 4543

Device Problem Material Integrity Problem (2978)

Patient Problems Unspecified Infection (1930); Sepsis (2067); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 03/06/2020

Event Type  Injury  

Manufacturer Narrative

The product has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint product, if there is any further relevant information from that review, a supplemental report will be filed.

Event Description

It was reported that this left ventricular (lv) lead was part of a system revision due to infection with sepsis.The patient was treated with intravenous antibiotics.The lead was explanted, however, the lead tip broke off and was left behind in the superior vena cava (svc).No additional adverse patient effects were reported.

Manufacturer Narrative

The product has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint product, if there is any further relevant information from that review, a supplemental report will be filed.Upon receipt at our post market quality assurance laboratory, the allegation against the lead was confirmed.Analysis showed that there were two lead segments that were returned, a terminal segment and a middle segment that was stretched out.The lead tip was not returned.A continuity test performed, and the lead passed indicating that the conductors were intact.No other abnormalities were observed on the returned segments other than severed.Corrected b2 filed: outcomes attrib to adv event and added patient code 3191 which captures the the additional intervention of intravenoues antibiotics and reportable event of surgery.

Event Description

It was reported that this left ventricular (lv) lead was part of a system revision due to infection with sepsis.The patient was treated with intravenous antibiotics.The lead was explanted, however, the lead tip broke off and was left behind in the superior vena cava (svc).No additional adverse patient effects were reported.

• Brand Name: EASYTRAK 2 IS-1
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9974413
• MDR Text Key: 188097207
• Report Number: 2124215-2020-06909
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410994
• UDI-Public: 00802526410994
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2016
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Device Lot Number: 188685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Date Manufacturer Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR