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

Model Number 419588

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

Patient Problems Unspecified Infection (1930); Perforation (2001); Pleural Effusion (2010); Cardiac Tamponade (2226)

Event Date 05/14/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: dtba1d1 crt-d implanted (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a pocket revision procedure signs of an infection were noted.The cardiac resynchronization therapy defibrillator (crt-d) system was removed due to the infection.While removing the left ventricular (lv) lead the patient experienced a perforation.The patient subsequently developed tamponade and pleural effusion.A sternotomy was performed and the patient was put on bypass and had to received units of blood.The patient was in critical condition.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN STARFIX LEAD
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 11939273
• MDR Text Key: 254278461
• Report Number: 2649622-2021-11250
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00885074511955
• UDI-Public: 00885074511955
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/13/2012
• Device Model Number: 419588
• Device Catalogue Number: 419588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2021
• Date Device Manufactured: 03/22/2011
• 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: 559445 LEAD, 694758 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 85 YR
• Patient Weight: 79