MAUDE Adverse Event Report: MPRI ATTAIN STARFIX; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 419588

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 06/01/2014

Event Type  Injury  

Event Description

It was reported the patient developed a pocket infection and there was erosion.This necessitated the removal of the device and leads.During the extraction of the left ventricular (lv) lead, the coronary vein was perforated.The patient developed pericardial tamponade requiring pericardiocentesis and repair of the coronary sinus and open chest resuscitation was performed.The patient was equipped with an external epicardial pacemaker system.Following resolution of the infection, the device and right ventricular (rv) lead as well as the right atrial (ra) lead were replaced.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Concomitant products: 4076 lead implanted: (b)(6) 2010; 4568 lead implanted: (b)(6) 2001.(b)(4).

• Brand Name: ATTAIN STARFIX
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM DISEASE MGMT; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: nashoane fulwood-kelley ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635260583
• MDR Report Key: 3991647
• MDR Text Key: 4891773
• Report Number: 2649622-2014-08011
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2014

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/15/2012
• Device Model Number: 419588
• Device Catalogue Number: 419588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2014
• Initial Date FDA Received: 08/08/2014
• Date Device Manufactured: 08/27/2010
• 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
• Treatment: 8042B IMPLANTABLE PULSE GENERATOR
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 00078 YR
• Patient Weight: 50