MAUDE Adverse Event Report: MEDTRONIC, INC. ATTAIN STARFIX LEAD; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P

Model Number 419588

Device Problem Device Handling Problem (3265)

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Date 06/10/2022

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.This event occurred outside the us.Patient information is limited due to confidentiality concerns.The event only occurred with one patient but specific details on the patient were not provided.The model listed in the report is a representative of the model family, as there is no specific model listed.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: hybrid transvenous and surgical approach for the extraction of coronary sinus leads: a case series.Pacing and clinical electrophysiology.2022;45:861¿865.Doi: 10.1111/pace.14536.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Literature was reviewed regarding hybrid transvenous and surgical approach for the extraction of coronary sinus leads.The authors d escribe a patient who presented with a fever.Transesophageal echocardiography revealed vegetations attached to the right ventricular (rv) lead, so a transvenous extraction of the system was performed.The left ventricular (lv) lead was difficult to extract.The procedure was terminated, and the patient was referred to the cardiothoracic surgeon.Control venography confirmed the integrity of t he superior vena cava (svc) and the coronary sinus.Transthoracic echocardiography confirmed the absence of pericardial effusion.Mini thoracotomy was performed, and the lead was retrieved.A new device and leads were reimplanted approximately one month later after the infection had resolved.The status of the device and leads is unknown.No additional adverse patient effects were reported.

• Brand Name: ATTAIN STARFIX LEAD
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 16667794
• MDR Text Key: 312596522
• Report Number: 2182208-2023-00906
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P060039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 419588
• Device Catalogue Number: 419588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• 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: DTBA2Q1 CRTD, 5554-45 LEAD, 693558 LEAD
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male