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

Model Number 429888

Device Problem Pacing Problem (1439)

Patient Problems Torsades-de-Pointes (2107); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132); Dizziness (2194)

Event Date 09/19/2018

Event Type  Injury  

Manufacturer Narrative

Referenced article: "qt interval prolongation and torsade de pointes induced by left ventricular pacing rescued by his bundle pacing" heart rhythm society; heart rhythm case reports, vol 6, no 6, june 2020 https://doi.Org/10.1016/j.Hrcr.2020.02.010.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding a case report of qt interval prolongation and torsade de pointes induced by left ventricular pacing and mitigated with his bundle pacing.The case report and information from technical services reported that the patient sustained several episodes of dizziness and near syncope with short runs of polymorphic ventricular tachycardia (vt) and extreme qt prolongation and ventricular fibrillation (vf) episodes suspected to be caused by lv pacing.A lead revision was performed, and the lead remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN PERFORMA 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: 10662496
• MDR Text Key: 211048932
• Report Number: 2649622-2020-19676
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601833
• UDI-Public: 00643169601833
• 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: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/05/2019
• Device Model Number: 429888
• Device Catalogue Number: 429888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2018
• Date Device Manufactured: 08/23/2017
• 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: 70 YR
• Patient Weight: 125