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

Model Number 429888

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

Patient Problems Bacterial Infection (1735); Death (1802); Dyspnea (1816); Endocarditis (1834); Hypoxia (1918); Unspecified Infection (1930)

Event Date 02/27/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the patient had presented to the hospital for worsening shortness of breath.It was noted the patient had been on antibiotics for upper respiratory tract symptoms and was diagnosed with acute on chronic hypoxemic respiratory failure secondaryto congestive heart failure and chronic obstructive pulmonary disease.A positive blood culture was observed for vancomycin-resistant enterococci (vre) with suspicion that it may have generated from the cardiac resynchronization therapy defibrillator (crt-d), along with infective endocarditis and infection classified as bacteremia/septicemia.A transesophageal echocardiogram (tee) was performed, which showed a probable vegetation on the right atrial (ra) lead.The patient was transferred to another facility and the crt-d system was later explanted and replaced.Approximately three months and three weeks following explant, the patient was noted to have passed away.Follow-up with the clinic was unable to provide further information related to the death of the patient.The patient is a participant in the post approval network (pan) clinical study.

Manufacturer Narrative

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

• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7749201
• MDR Text Key: 116034971
• Report Number: 2649622-2018-12761
• Device Sequence Number: 0
• Product Code: OJX
• 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,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/17/2018
• Device Model Number: 429888
• Device Catalogue Number: 429888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 08/03/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/03/2018
• Date Device Manufactured: 11/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 88