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

Model Number W1TR01

Device Problems Pacing Problem (1439); Capturing Problem (2891)

Patient Problems Chest Pain (1776); Tachycardia (2095)

Event Date 04/05/2022

Event Type  Injury  

Event Description

It was reported that an atrial tachycardia was induced during in-office threshold testing of the left ventricular lead.The patient reportedly had a history of atrial tachycardia being induced during device interrogations.The patient could feel it but tolerated it well.The patient confirmed having felt this sensation at least twice a day for as long as they could remember.The tachycardia spontaneously terminated but recurred when threshold testing was attempted again.It was determined by a healthcare professional that this was a form of pacemaker-mediated tachycardia induced with left ventricle (lv)-only pacing.These episodes were recorded by thecardiac resynchronization therapy pacemaker (crt-p) as atrial tachycardia/atrial fibrillation (at/af).It was noted that at/af episodes would occur at times when the device feature which monitors pacing thresholds may have just run.When the patient was left ventricle (lv)-only pacing, the signal was delayed on the right atrial (ra) channel, falling outside the blanking and refractory periods, and was oversensed.As the at/af episodes were likely being triggered by lv threshold testing, the device feature which monitors pacing thresholds was turned off.It was also noted that the patient had experienced some chest pain during times of peak activity.An exercise stress test suggested the patient might have been feeling dropped beats once the crt-p had reached the upper rate limit.The upper tracking rate was increased which improved the patient¿s symptom.The crt-p and ra lead remain in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Concomitant medical products: 4968-25 lead implanted: (b)(6) 2009.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PERCEPTA 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: 14315387
• MDR Text Key: 291312798
• Report Number: 9614453-2022-01305
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00643169891401
• UDI-Public: 00643169891401
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/14/2022
• Device Model Number: W1TR01
• Device Catalogue Number: W1TR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2022
• Date Device Manufactured: 11/19/2020
• 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: 511211 LEAD, 4965-35 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR
• Patient Sex: Male