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

Model Number 439888

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

Patient Problems Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient experienced implant-related tamponade on the day of the cardiac resynchronization therapy defibrillator (crt-d) system implant.It was noted during the patient's hospitalization following the tamponade, the patient experienced arterial hypotension, as the patient's blood pressure dropped likely due to hypovolemia.The patient was given saline and intravenous infusion of nor-epinephrine.Two days later the patient's blood pressure stabilized and the nor-epinephrine was discontinued.The system remains in use.The patient is a participant in the (b)(6) 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.

Event Description

Further information was received, which indicated four hours following the implant, the patient experienced chest pain accompanied by a drop in blood pressure.A quicklook echocardiac was done and a pericardial circumferential effusion was observed.A pericardiocentesis was done and a pericardial drain was put in place.200 ml of blood was removed and the blood pressure increased.The patient was hospitalized and a new quicklook echo was done and no further pericardial effusion was observed.The drain was removed and the subject was discharged.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN PERFORMA
• 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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8197412
• MDR Text Key: 131432090
• Report Number: 2649622-2018-21270
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/13/2020
• Device Model Number: 439888
• Device Catalogue Number: 439888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2019
• Date Device Manufactured: 08/21/2018
• 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: DTMB2Q1 CRTD, 4076-52 LEAD, 6935-65 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 87