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

Model Number 429888

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

Patient Problems Chest Pain (1776); Perforation of Vessels (2135)

Event Date 09/15/2018

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 was admitted to the hospital with chest pain.The patient is a participant in the (b)(6) clinical study.It was noted that the patient¿s troponin (tnl) levels were elevated and an echo showed low left ventricular end-diastolic (lved).A coronary angiography was performed which showed an artery fistula at the distal left anterior descending (lad) with the left ventricular (lv) lead possibly puncturing the distal lad near the apical septum.It was indicated that this appears to suggest a migration of the lead tip into the apical septum.The patient was discharged and evaluated by the study primary investigator (pi) approximately five days later.The pi suggested an ablation and change of medications.The patient was eventually admitted to the hospital again and the cardiologist modified the patients antiarrhythmic medications while under hospital supervision.The lead currently remains in use.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.

Event Description

It was further reported that lead had dislodged.A surgical intervention was completed and the lead remains in use.No 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: 7985699
• MDR Text Key: 124462905
• Report Number: 2649622-2018-17122
• 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,Followup
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/22/2016
• Device Model Number: 429888
• Device Catalogue Number: 429888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2018
• Date Device Manufactured: 09/19/2014
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 88 YR
• Patient Weight: 70