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

Model Number 439888

Device Problem Failure to Capture (1081)

Patient Problem Asystole (4442)

Event Date 05/16/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced asystole due to a loss of capture with the left ventricular (lv) lead when the cardiac resynchronization therapy defibrillator (crt-d) feature that monitors the pacing amplitude threshold and adjusts the right ventricular lead outputs was trying to run.It was noted that the patient had three minutes of an asystole episode requiring cardiopulmonary resuscitation.It was also noted that the loss of capture was possibly due to having only lv capture at the time the feature started running.When the feature started running the device switched from bi-ventricular (bi-v) pacing to right ventricular (rv) lead only pacing, therefore losing capture.Threshold variability was also noted, but trending shows the threshold has been stable.An x-ray revealed that the rv lead was found to have a macro-dislodgment from the mid-septal placement to the apex.The device time was also one hour ahead of the local time.The device remains in use.Reprogramming was done to the lv lead and the rv lead was explanted and replaced.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 reported that the patient experienced asystole due to a loss of capture with the left ventricular (lv) lead when the cardiac resynchronization therapy pacemaker (crt-p) feature that monitors the pacing amplitude threshold and adjusts the right ventricular lead outputs was trying to run.It was noted that the patient had three minutes of an asystole episode requiring cardiopulmonary resuscitation.It was also noted that the loss of capture was possibly due to having only lv capture at the time the feature started running.When the feature started running the device switched from bi-ventricular (bi-v) pacing to right ventricular (rv) lead only pacing, therefore losing capture.Threshold variability was also noted, but trending shows the threshold has been stable.Review of the historical data retrieved from the crt-p memory interrogation report revealed varying and high threshold measurements of the right atrial (ra) lead.An x-ray revealed that the rv lead was found to have a macro-dislodgment from the mid-septal placement to the apex.The device time was also one hour ahead of the local time.Reprogramming was done to the lv lead and the device, ra lead and lv lead remain in use.The rv lead was explanted and replaced.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Correction: b5 and c: combination product drugs.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN PERFORMA STRAIGHT 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: 14604934
• MDR Text Key: 293432592
• Report Number: 2649622-2022-10845
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601857
• UDI-Public: 00643169601857
• Combination Product (y/n): Y
• 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,Followup
• Report Date: 06/13/2022

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: Lay User/Patient
• Device Expiration Date: 08/11/2023
• Device Model Number: 439888
• Device Catalogue Number: 439888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 06/06/2022
• Supplement Dates Manufacturer Received: 05/17/2022
• Supplement Dates FDA Received: 06/13/2022
• Date Device Manufactured: 08/30/2021
• 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
• Treatment: W4TR01 CRTP, 5076-45 LEAD, 5076-52 LEAD
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female