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

Model Number 4195

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problems Erosion (1750); Unspecified Infection (1930); Pocket Erosion (2013)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.This event occurred outside the us.Patient information is limited due to confidentiality concerns.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: ¿first-in-man fully leadless transvenous crt-p with a transseptal implant of wise-crt®system and micra®pm.¿ pace - pacing and clinical electrophysiology.2019; 42(11):1489-1492.Doi://10.1111/pace.13750.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding a case study of the first fully leadless transvenous cardiac resynchronization therapy pacemaker (crt-p) implant with a leadless implantable pulse generator (ipg) implant.It was reported that with the patient's previous system, the patient experienced previous pocket infections, the most recent being due to staphylococcus epidermidis.The patient was treated with antibiotic therapy and a local dressing.Later the same year, the patient was hospitalized due to device exposure with signs of system infection by s.Epidermidis.The patient's lead was attempted to be extracted, however, the lead fractured and was left in place due to negative cultures tests on the extracted portion of the lead.The status of the extracted lead portion is unknown.Further follow up did not yet yield any additional information.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): 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: 9759444
• MDR Text Key: 181971800
• Report Number: 2182208-2020-00388
• 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,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• 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
• Date Manufacturer Received: 02/05/2020
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 82 YR