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 Hematoma (1884); Unspecified Infection (1930); Necrosis (1971); Swelling (2091); Thrombosis (2100); Discharge (2225)

Event Date 03/25/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: evolutr-34-us, transcatheter valve, 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 developed a pocket hematoma/infection.It was noted that during a routine follow up examination, the implant site was swollen and ecchymotic.It was further reported that approximately six-days later a large clot and necrotic tissue was observed.Antibiotics was administered and the cardiac resynchronization therapy defibrillator (crt-d) system was explanted and replaced with a leadless implantable pulse generator (ipg).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

Product event summary: the distal portion of the lead was returned, analyzed, and no anomalies were found.Visual analysis of the lead indicated apparent explant damage.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information received noted the patient reported a cyst under the left arm pit that opened and had yellow/green discharge prior to the routine follow up exam.

• 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: 8633371
• MDR Text Key: 145840188
• Report Number: 2649622-2019-08766
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/03/2016
• Device Model Number: 459888
• Device Catalogue Number: 459888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2019
• Initial Date FDA Received: 05/22/2019
• Supplement Dates Manufacturer Received: 05/24/2019; 02/26/2020
• Supplement Dates FDA Received: 05/28/2019; 02/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2014
• 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: DTBA1QQ ICD, 5076-52 LEAD, 6947M62 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 72