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

Model Number W1TR04

Device Problem Misconnection (1399)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that an alert triggered on the right ventricular (rv) lead for high undefined pacing impedance, possibly due to fracture.The patient presented to the hospital for a device check.Normal impedance values were observed until pocket manipulation reproduced the high impedance.The pocket was reopened to check the connection between the cardiac resynchronization therapy pacemaker (crt-p) and rv lead to try and confirm a loose connector pin or lead fracture.The lead was easily removed from the crt-p without using a torque wrench.Stable impedance measurements were observed via testing with an analyzer and a loose connector pin was suspected.The physician believed the connection issue was a result of the patient¿s recent device replacement.The lead was re-connected and the crt-p and lead remain in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Clinical data review was determined to not be required because the complaint cannot be substantiated via clinical data review.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
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9251419
• MDR Text Key: 164275531
• Report Number: 9614453-2019-03659
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

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: 12/28/2020
• Device Model Number: W1TR04
• Device Catalogue Number: W1TR04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 10/30/2019
• Supplement Dates FDA Received: 11/01/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/12/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR