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

Model Number 419588

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

Patient Problems Unspecified Infection (1930); Cardiac Perforation (2513)

Event Date 01/15/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: ldp210q lead, implanted: (b)(6) 2015; st jude lead, implanted: (b)(6) 2015.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient developed an infection and the left ventricular (lv) lead was explanted and replaced.During the extraction procedure, there was a complication and the patient chest had to be opened.It was noted that the lead, unbeknownst to the physician, had ¿scared¿ into not only the venous system where the lead was deployed, but also to the arterial system.Therefore, causing an arterial bleed when the lead was extracted.Repair to the tear was made.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) PACEMAKER ELECTRODE
• 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: 11286981
• MDR Text Key: 230520118
• Report Number: 2649622-2021-02336
• 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: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/18/2017
• Device Model Number: 419588
• Device Catalogue Number: 419588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2021
• Date Device Manufactured: 07/13/2015
• 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: 1788TC LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 87 YR