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

Model Number W4TR04

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Mechanical Problem (1384); Capturing Problem (2891)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 479888 lead, implanted: (b)(6) 2021.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there was high undefined pacing impedance on the right ventricular (rv) lead.The physician considered replacing the lead as a lead fracture or loose pin could not be confirmed by an x-ray.At a pre-procedure check, a noise-like event was confirmed and the threshold increased on the rv lead.During the procedure the device was removed and a loose pin was not confirmed.The rv lead was removed from the header and examined, the impedance and threshold were noted to be normal.Movement of the rv setscrew was visually confirmed, however, there was no problem with the setscrew itself.When the rv lead was connected back to the device, there was no issue with the impedance and threshold values.It was noted that the setscrew may not have been initially set properly.The physician chose to close the pocket and the device and lead remain in use.No patient complications have been reported as a result of this event.

• 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: 12274658
• MDR Text Key: 264976060
• Report Number: 9614453-2021-03106
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P010015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/28/2022
• Device Model Number: W4TR04
• Device Catalogue Number: W4TR04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2021
• Date Device Manufactured: 11/12/2020
• 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: 5076-52 LEAD, 5076-58 LEAD
• Patient Age: 77 YR