MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL PERCEPTA QUAD CRTP; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

Model Number W4TR01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Unspecified Infection (1930); Chills (2191)

Event Date 03/09/2018

Event Type  Injury  

Manufacturer Narrative

Product event summary: the device was returned and analyzed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the cardiac resynchronization therapy defibrillator (crt-d) system was removed due to infection and erosion of the device through the skin.The patient was treated with antibiotics.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

The infection was later elaborated upon to be bacteremia and/or septicemia and the patient had recently experienced chills.The patient is a participant in the post approval clinical surveillance product surveillance registry.

• Brand Name: PERCEPTA QUAD CRTP
• 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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 7460012
• MDR Text Key: 106479984
• Report Number: 9614453-2018-01412
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/14/2019
• Device Model Number: W4TR01
• Device Catalogue Number: W4TR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2018
• Initial Date FDA Received: 04/25/2018
• Supplement Dates Manufacturer Received: 03/22/2019
• Supplement Dates FDA Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2017
• 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: 429888 LEAD, 5076-45 LEAD, 5076-52 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 90 YR
• Patient Weight: 49