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

Model Number W1TR06

Device Problem Mechanical Problem (1384)

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

Event Date 10/06/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during the implant procedure, it was impossible to connect the right ventricular (rv) lead to the cardiac resynchronization therapy pacemaker (crt-p) due to a setscrew problem.The device was not used and replaced.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.The returned device indicated the rv grommet was loose/detached, had damage to the bottom of the grommet with foreign material (fm) on the bottom surface of the grommet.The returned device indicated a loose/detached rv set screw with a rounded socket, a damaged setscrew socket, damage to the setscrew head, damage to the setscrew threads and fm on the setscrew threads.The returned device indicated the rv setscrew block was damaged.The returned device indicated the lv set screw was found in the connector bore, the setscrew sock was rounded and fm on the setscrew threads.The returned device indicated the lv grommet had fm on the bottom surface of the grommet.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SOLARA 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7094034
• MDR Text Key: 94676343
• Report Number: 9614453-2017-04509
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2019
• Device Model Number: W1TR06
• Device Catalogue Number: W1TR06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2017
• 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