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

Model Number W4TR03

Device Problems Failure to Interrogate (1332); Pacing Problem (1439); Battery Problem (2885)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 10/07/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the patient went into cardiac arrest/asystole and presented to the emergency room.The cardiac resynchronization therapy pacemaker (crt-p) was unable to be interrogated using multiple programmers.There was no pacing output observed from the device and it was suspected the battery was depleted.It was noted the device did not respond when a magnet was placed on it.Cardioversion was attempted and the patient received cardiopulmonary resuscitation (cpr) while a temporary pacing lead was inserted.The device was scheduled for replacement.It was added the patient was not doing well and placed on life support and the family/physician were leaning towards withdrawing all care going forward.The patient passed away two days later.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.The returned device indicated leakage in the hybrid.Hybrid analysis determined that the anomalous current drain was due to a faulty c12 capacitor.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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 8031501
• MDR Text Key: 125900144
• Report Number: 9614453-2018-03805
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00643169891456
• UDI-Public: 00643169891456
• 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: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2019
• Device Model Number: W4TR03
• Device Catalogue Number: W4TR03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2017
• 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: 4298-88 LEAD, 5076-52 LEAD
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR