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 Problem Pacing Problem (1439)

Patient Problem Bradycardia (1751)

Event Date 10/17/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 5071-53, lead, implanted: (b)(6) 2021, 5071-53, lead, implanted: (b)(6) 2021. If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the left ventricular (lv) lead had a suspected loss of capture. The healthcare professional indicated that the patient¿s pulse was in the 30-40¿s which was lower than the programmed lower rate of the cardiac resynchronization therapy pacemaker (crt-p). The device and lead remain in use. No further patient complications have been reported as a result of this event.

• 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: 12771116
• MDR Text Key: 280530322
• Report Number: 9614453-2021-04214
• Device Sequence Number: 1
• Product Code: NKE
• 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

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: W1TR01
• Device Catalogue Number: W1TR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 05/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/08/2021 Patient Sequence Number: 1

Treatment

5076-58 LEAD, 5076-52 LEAD