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

Model Number W1TR03

Device Problem Mechanical Problem (1384)

Patient Problems Syncope (1610); Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817)

Event Date 06/13/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the left ventricular (lv) lead was exhibiting intermittent or complete loss of capture and high thresholds.The patient reportedly experienced syncope and asystole with long pauses noted.A procedure was planned to replace the cardiac resynchronization therapy defibrillator (crt-d) as there was thought to be a device header issue stemming from the recent implant.The right ventricular (rv) lead was tested via the analyzer during the procedure and tested normally; however, the lead exhibited intermittent or complete loss of capture when connected to the crt-d.The crt-d was replaced and normal rv and lv lead function was noted.The following day, intermittent loss of capture was again noted on the rv lead.The lead was capped and replaced.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 reported device was a cardiac resynchronization therapy pacemaker (crt-p) not a cardiac resynchronization therapy defibrillator (crt-d).

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.

Manufacturer Narrative

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: 7665183
• MDR Text Key: 113270944
• Report Number: 9614453-2018-02500
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00643169891449
• UDI-Public: 00643169891449
• 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,Followup,Followup
• Report Date: 10/25/2018

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: 04/14/2019
• Device Model Number: W1TR03
• Device Catalogue Number: W1TR03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 07/05/2018
• Supplement Dates Manufacturer Received: 06/13/2018; 08/09/2018; 10/25/2018
• Supplement Dates FDA Received: 07/11/2018; 08/10/2018; 10/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2017
• 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: 5076-52 LEAD, 5076-58 LEAD, 429688 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR