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

Model Number 4195

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Bacterial Infection (1735); Cardiac Arrest (1762); Death (1802); Endocarditis (1834); Hemorrhage/Bleeding (1888); Occlusion (1984); Sepsis (2067); Swelling (2091); Thrombosis (2100); Ventricular Fibrillation (2130); Heart Failure (2206); Cardiac Tamponade (2226); Stenosis (2263); Ischemic Heart Disease (2493); Cardiac Perforation (2513); Loss Of Pulse (2562); Blood Loss (2597); Pericardial Effusion (3271)

Event Date 01/01/2016

Event Type  Death  

Manufacturer Narrative

This information is based entirely on journal literature.All information provided is included in this report.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique lead/serial numbers patient information is limited due to confidentiality concerns.The date of death is purely an estimate, as there is no indication of specific serial number/patient information.The gender of the baseline characteristics is male and the baseline age is (b)(6).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.Referenced article: extraction of chronically implanted coronary sinus leads active fixation vs.Passive fixation leads, heart rhythm.(b)(4).

Event Description

A journal article was reviewed which contained information regarding leads.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique lead/serial numbers.The article indicated that there were patient deaths; due to progressive sepsis, progressive heart failure, multi-system failure, and one related to the lead extraction procedure (coronary sinus tear and subsequent bleeding).Additional adverse events noted were: angioedema, cardiac arrest, cardiac tamponade, cellulitis, incision cite hemorrhage, incision site infection, mediastinal hemorrhage, pericardial effusion, myocardial ischemia, pulmonary embolism, pulse-less electrical activity (pea), and ventricular fibrillation (vf) with cardio-version.The status of the leads is unknown; however, the leads appear to have been extracted.Indications for extractions include: non-functional leads, pocket abscess, device erosion, valvular endocarditis, lead endocarditis, lead occlusion, occult gram-positive bacteremia, design or failure of lead, leads preventing access , localized pocket infection, thrombosis or venous stenosis, persistent occult gram- negative bacteremia,and non-functional leads removed due to physician discretion.Further follow up did not yet yield any additional relevant information regarding the event.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN STARFIX
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5430194
• MDR Text Key: 37998950
• Report Number: 2182208-2016-00691
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4195
• Device Catalogue Number: 4195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2016
• 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: IMPLANTABLE PULSE GENERATOR (IPG)
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 00068 YR