MAUDE Adverse Event Report: MPRI ATTAIN STABILITY QUAD MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P

Model Number 479888

Device Problems Low impedance (2285); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009); High Capture Threshold (3266)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 01/27/2022

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 left ventricular (lv) lead implant, there was difficulty placing the lead.Upon testing the lead, several low impedance measurements were recorded with high threshold.The lead was placed into another vessel where normal impedances were measured with slightly better thresholds.After placement the patient began to show signs of cardiac tamponade.The patient became hypotensive and they physician suspected a perforation may have occurred.An echocardiogram revealed a pericardial effusion.Pericardiocentesis was performed and a pericardial drain was placed.The lv lead was removed.The patient was intubated for the remainder of the procedure. no further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN STABILITY QUAD MRI SURESCAN
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P
• 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: 13446638
• MDR Text Key: 285034190
• Report Number: 2649622-2022-02481
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169860421
• UDI-Public: 00643169860421
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2022

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: Health Professional
• Device Expiration Date: 10/19/2023
• Device Model Number: 479888
• Device Catalogue Number: 479888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/03/2022
• Date Device Manufactured: 11/08/2021
• 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; Life Threatening
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 41 KG