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

Model Number 439888

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Stimulation (1412); Pleural Effusion (2010)

Event Date 03/26/2016

Event Type  Injury  

Event Description

It was reported that the left ventricular (lv) lead dislodged with forward migration.During the repositioning procedure, it was noted that there was a pleural effusion that was related to the procedure.As a result, the patient underwent a left and right sided thoracentesis.The lv lead was repositioned and remains in use.The patient is a participant in (b)(6).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.

Manufacturer Narrative

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

Event Description

It was also reported that initially the patient had gone to the emergency room with complaint of a palpitation sensation with hiccups; feeling like their abdomen was jumping.The sensation was determined to be diaphragmatic stimulation from the left ventricular lead due to the dislodgement.The lead was programmed off at that time and subsequently repositioned.

• 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: 6626983
• MDR Text Key: 77200251
• Report Number: 2649622-2017-06479
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169002517
• UDI-Public: 00643169002517
• 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: 10/24/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2017
• Device Model Number: 439888
• Device Catalogue Number: 439888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2017
• Initial Date FDA Received: 06/08/2017
• Supplement Dates Manufacturer Received: 03/03/2017; 10/05/2018
• Supplement Dates FDA Received: 10/02/2017; 10/24/2018
• Date Device Manufactured: 01/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 57