MAUDE Adverse Event Report: MPRI ATTAIN PERFORMA S MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 459878

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

Patient Problems Diarrhea (1811); Endocarditis (1834); Fever (1858); Low Blood Pressure/ Hypotension (1914); Insufficiency, Valvular (1926); Unspecified Infection (1930); Sepsis (2067); Thrombus (2101); Chills (2191)

Event Date 12/11/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 407652 lead, implanted: (b)(6) 2018; 407645 lead, implanted: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced infection.The entire system was explanted and later replaced.No further patient com plications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that the patient was admitted with body aches, fever, chills, and diarrhea.Endocarditis was also noted.Blood cultures grew (b)(6).The next day the patient became hypotensive and was admitted to the critical care unit on suspicion of sepsis due to (b)(6).The patient's ejection fraction (ef) decreased to 29%.Computed tomography angiography (cta) showed thrombus or infection lesions on the aortic valve and the leads.The entire system was then explanted, with the patient placed on a temporary pacemaker until permanent replacement days later.The patient had also been given (b)(6) two days prior to admission.The patient is a participant in the post approval clinical surveillance product surveillance registry.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN PERFORMA S MRI SURESCAN
• 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: 8220517
• MDR Text Key: 132196686
• Report Number: 2649622-2019-00233
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601864
• UDI-Public: 00643169601864
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/19/2019
• Device Model Number: 459878
• Device Catalogue Number: 459878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2019
• Date Device Manufactured: 11/07/2017
• 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; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 42