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

Model Number 429888

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Thrombosis (2100)

Event Date 01/23/2018

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 a left ventricular thrombus.Medication was administered, which resolved the thrombus and the left ventricular (lv) lead remain 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.

• 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: 7634601
• MDR Text Key: 112206520
• Report Number: 2649622-2018-10443
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169002715
• UDI-Public: 00643169002715
• 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
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/29/2016
• Device Model Number: 429888
• Device Catalogue Number: 429888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2018
• Date Device Manufactured: 08/19/2014
• 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, 5076-45 LEAD, 6935M55 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 76