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

Model Number W4TR04

Device Problems Failure to Capture (1081); Mechanical Problem (1384)

Patient Problem Dizziness (2194)

Event Date 02/21/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical product: 5076-58 lead.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was presyncopal.The right ventricular (rv) lead was found to have no capture at high output four days after implant of a new device.The patient was brought back for a device revision.When inspecting the header, the lead appeared to be fully inserted.The physician decided to replace the lead as the patient was 100% pacing dependent.The new lead had good numbers when tested through the analyzer.When the lead was inserted into the device it was not capturing as maximum output.The physician recalled that the rv setscrew had felt a little tight during the implant.The device was then explanted and a new device was implanted.The new rv lead was inserted and testing revealed good parameters.The new rv lead and device remain in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated the impedance of the atrial pacing lead was beyond the expected upper range.Analysis of the device memory indicated the impedance of the right ventricular pacing lead was beyond the expected upper range.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• 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: 8433749
• MDR Text Key: 139236262
• Report Number: 9614453-2019-00854
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/14/2019
• Device Model Number: W4TR04
• Device Catalogue Number: W4TR04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR