MAUDE Adverse Event Report: MPRI ATTAIN PERFORMA STRAIGHT MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P

Model Number 439888

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

Patient Problems Dyspnea (1816); Pulmonary Edema (2020); Dizziness (2194); Swelling/ Edema (4577)

Event Date 05/30/2017

Event Type  Injury  

Event Description

It was reported that after the implant of the left ventricular (lv) lead, the patient experienced heart failure exacerbation with a drop in ejection fraction over the last year.The patient experienced dyspnea, dizziness, and lower limb edema.A chest x-ray was performed and pulmonary edema was observed.The patient's medication was adjusted and the lv lead remains in use.The patient is a participant in a clinical study.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 STRAIGHT MRI SURESCAN
• 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: 13721785
• MDR Text Key: 286941605
• Report Number: 2649622-2022-04697
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/27/2019
• Device Model Number: 439888
• Device Catalogue Number: 439888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2022
• Date Device Manufactured: 04/11/2017
• 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
• Treatment: 716692 CRTP
• Patient Outcome(s): Required Intervention