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

Model Number 439878

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

Patient Problems Perforation of Vessels (2135); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 08/07/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during a competitive device upgrade procedure, while implanting the left ventricular (lv) lead, the lead could not be advanced far enough along the posterior lateral cardiac vein so it was decided to attempt via the middle cardiac vein.Contrast was delivered and a perforation of the middle cardiac vein was noted.Additional information reported that the patient experienced a pericardial effusion which resulted in tamponade.A pericardiocentesis was performed and a drain was placed.The lead was removed and the implant attempt was abandoned.The patient will be implanted with an epicardial lead at a later date.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN PERFORMA STRAIGHT 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: 10492008
• MDR Text Key: 205652662
• Report Number: 2649622-2020-16936
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601840
• UDI-Public: 00643169601840
• 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: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2020
• Device Model Number: 439878
• Device Catalogue Number: 439878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2020
• Date Device Manufactured: 10/12/2018
• 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: 67 YR