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

Model Number 459888

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

Patient Problems Abscess (1690); Endocarditis (1834); Unspecified Infection (1930)

Event Date 06/02/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 694765 lead, implanted: (b)(6) 2002.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a hospitalization for an exacerbation of congestive heart failure, the patient had a transesophageal echocardiogram performed which showed vegetation on the tricuspid, mitral and aortic valves as well as a tricuspid abscess.Blood cultures were performed and were positive for gram positive cocci, enterococcus faecalis.The patient was diagnosed with acute bacterial endocarditis, and bacteremia/septicemia.The cardiac resynchronization therapy defibrillator (crt-d) system was explanted.A peripherally inserted central catheter was placed and the patient treated with intravenous antibiotics.The patient was discharged to an acute care facility with a life vest.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.

• 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: 8906720
• MDR Text Key: 154750088
• Report Number: 2649622-2019-14618
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169169081
• UDI-Public: 00643169169081
• 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
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/23/2016
• Device Model Number: 459888
• Device Catalogue Number: 459888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2019
• Date Device Manufactured: 12/12/2014
• 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: DTBA1Q1 CRTD, 5076-52 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 169