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

Model Number W4TR06

Device Problems Mechanical Problem (1384); Misconnection (1399)

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

Event Date 03/03/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: unknown lead, implant date: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the left ventricular (lv) lead dislodged.The lead was reportedly repositioned but was ultimately replaced.The physician was unable to secure the new lv lead in the cardiac resynchronization therapy pacemaker's (crt-p) lv port and it was loose.The lead pin was fully inserted but there was a problem with the lv port setscrew.The crt-p was replaced and there were no further issues.No patient complications have been reported as a result of this event.

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.

• Brand Name: SOLARA 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: 8461460
• MDR Text Key: 140216807
• Report Number: 9614453-2019-01024
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/14/2020
• Device Model Number: W4TR06
• Device Catalogue Number: W4TR06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2018
• 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: 4598-88 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 130