MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL PERCEPTA QUAD CRT-P MRI SURESCAN; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number W4TR01

Device Problems Pacing Problem (1439); Device Sensing Problem (2917)

Patient Problem Dyspnea (1816)

Event Date 05/30/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 459888, lead, implanted: (b)(6) 2021.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.

Event Description

It was reported that during use of the cardiac resynchronization therapy pacemaker (crt-p), the patient stated, "it's rather odd, they turned on the anti-tachycardia pacing (atp), and only to discover that the atp therapy was turned off approximately six months later, i was in heart failure for a year.Recently, they tried to turn on the atp and i got this shooting pain in my heart and accompanied with belching, and when i had the atp went off.The event record read, and that went off at the same exact time that the atp therapy did.She lowered the output and then tried the atp again and i could not tolerate it.I didn't see the doctor, and he was not there.And i went in today and spoke to the nurse practitioner.I am worried that something is wrong with the device.It's has to be the machine.The medtronic girl had medtronic on the phone for a half hour and they couldn't figure it out.All i could find out from the nurse today, was to call medtronic.I am getting a little short of breath.There has to be something going on with my device.I told her that it just started." the patient was referred to the physician.The crt-p remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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.

Event Description

It was further reported that the sharp pains were intermittent and not dependent on device feature operation.It was also noted that the atrial atp therapy was currently programmed off but would be reactivated after a cardioversion procedure.

• Brand Name: PERCEPTA QUAD CRT-P MRI SURESCAN
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 15315911
• MDR Text Key: 298869994
• Report Number: 9614453-2022-02657
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00643169891418
• UDI-Public: 00643169891418
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2023

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: 12/14/2022
• Device Model Number: W4TR01
• Device Catalogue Number: W4TR01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 08/29/2022
• Supplement Dates Manufacturer Received: 09/29/2023
• Supplement Dates FDA Received: 10/24/2023
• Date Device Manufactured: 06/18/2021
• 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: 5076-52 LEAD, 5076-45 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female