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

Model Number 459888

Device Problems Failure to Capture (1081); Device Dislodged or Dislocated (2923)

Patient Problems Cardiopulmonary Arrest (1765); Electro-Mechanical Dissociation (1826)

Event Date 05/14/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the day after the implant of a cardiac resynchronization therapy pacemaker (crt-p) system and an atrioventricular ar node ablation, the patient was found to be in pulseless electrical activity.Cardiopulmonary resuscitation (cpr) was performed.A chest x-ray showed that the right ventricular (rv) lead had dislodged and the left ventricular (lv) lead had pulled back.The rv lead and lv lead exhibited no capture, and a temporary pacemaker was placed.Later in the morning, reprogramming was done with the implanting physician and the leads remain in use.The physician stated that the patient had other medical issues which contributed to the patient's situation that was unrelated to the leads.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN PERFORMA S 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: 10114113
• MDR Text Key: 193615724
• Report Number: 2649622-2020-10468
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601871
• UDI-Public: 00643169601871
• 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: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/20/2022
• Device Model Number: 459888
• Device Catalogue Number: 459888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2020
• Date Device Manufactured: 03/09/2020
• 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
• Treatment: 5076-58 LEAD, W4TR01 CRT-P, 5076-52 LEAD
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 84