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

Model Number 459888

Device Problems Intermittent Capture (1080); Failure to Capture (1081); High Capture Threshold (3266)

Patient Problems Arrhythmia (1721); Bradycardia (1751); Chest Pain (1776); Dyspnea (1816); Muscle Weakness (1967); Presyncope (4410)

Event Date 08/22/2023

Event Type  Injury  

Event Description

It was reported that the patient had been having spells with no energy.The patient reported having an irregular heartbeat and blood pressure and reported a heart rate of fifty-seven beats per minute though the cardiac resynchronization therapy pacemaker (crt-p) was set at sixty beats per minute.Their rate would reportedly be normal for four or five beats and then it would "bump." medics came and performed an electrocardiogram and told the patient their heart was working fine, and the crt-p was "kicking".Follow up with the physician office noted that the patient had an in-office check done.It was noted that the left ventricular (lv) lead had intermittent no capture.The patient reported feeling poorly and noted that the feeling has gotten worse since starting heart failure medication and a water pill.It was noted that the patient was having chest pains and feeling a lot of abnormal heart beats.It was further reported that the patient had chest pressure, shortness of breath and near syncope.Reprogramming was done, and the device and lead remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

D10/d11: concomitant medical products: w4tr01 crtp; 5076-58 implanted: (b)(6) 2019.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.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.

Event Description

It was reported that the patient had been having spells with no energy.The patient reported having an irregular heartbeat and blood pressure and reported a heart rate of fifty seven beats per minute though the cardiac resynchronization therapy pacemaker (crt-p) was set at sixty beats per minute.Their rate would reportedly be normal for four or five beats and then it would "bump." medics came and performed an electrocardiogram and told the patient their heart was working fine and the crt-p was "kicking".The crt-p remains in use. no further patient complications have been reported as a result of this event.Additional information received from the physician office noted that the patient had an in-office check done.It was noted that the left ventricular (lv) lead hadintermittent no capture.The patient reported feeling poorly and noted that the feeling has gotten worse since starting heart failure medication and a water pill.It was noted that the patient was having chest pains and feeling a lot of abnormal heart beats.It was further reported that the patient had chest pressure, shortness of breath and near syncope.Reprogramming was done, and the lead remains i n use.Additional information reported that the lv lead exhibited increased threshold and non-capture.

Manufacturer Narrative

Correction: b5; h6 device codes (fdd/annex a).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 S 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: 17869487
• MDR Text Key: 324903723
• Report Number: 2649622-2023-27075
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/26/2020
• Device Model Number: 459888
• Device Catalogue Number: 459888
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2023
• Date Device Manufactured: 10/17/2018
• 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
• Treatment: T505C29 TISSUE VALVE
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Weight: 91 KG