MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSISST) BYPASS

Model Number 106524

Device Problems Electromagnetic Interference (1194); Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 08/01/2021

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is complete.

Event Description

It was reported through the research abstract "heartmate 3 ecg interference, does it lead to inappropriate icd shocks?" that heartmate 3 (hm3) devices may play a role in electromagnetic interference.The study was a single center retrospective study examining inappropriate implanted cardioverter-defibrillator (icd) discharge in hm3 patients.A total of 20 hm3 patients were evaluated.All patients had ecgs with high frequency electromagnetic interference (emi).Of the 4 patients who experienced icd shocks, only one was deemed inappropriate.This patient had a subcutaneous-icd (s-icd) which the other patients did not.The patient received multiple shocks shortly after hm3 implant.This study suggests that avoidance of s-icds in patients that are potential candidates for hm3 implantation who have normal function of trans-venously implanted defibrillators.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the heartmate 3 devices and the reported magnetic interference could not be conclusively determined through this evaluation.The research article titled ¿heartmate 3 ecg interference, does it lead to inappropriate icd shocks?¿ identified that patients implanted with a heartmate 3 left ventricular assist device (lvad) and an implantable cardioverter defibrillator (icd) may have the potential for inappropriate icd shocks due to magnetic interference with the lvad.The study referenced in the research abstract consisted of 20 patients who were implanted with a heartmate 3 device and an icd.The article identified that 1 of the patients experienced an inappropriate shock from their icd.The patient who experienced the inappropriate shock had a pre-existing subcutaneous implantable cardioverter defibrillator (s-icd).The heartmate 3 device serial numbers and other specific case/patient information is not available and was not requested.No product was evaluated under this complaint.The device history records could not be reviewed because the serial numbers of the implanted heartmate 3 devices are unknown.Heartmate 3 (hm3) left ventricular assist system (lvas) instructions for use (ifu) rev.C contains warnings in the introduction, surgical procedures, and patient care and management sections that that the pump may cause interference with icds (implantable cardioverter defibrillators).If electromagnetic interference occurs it may lead to inappropriate icd therapy.The occurrence of electromagnetic interference with icd sensing may require adjustment of device sensitivity and/or repositioning the lead.Prior to implanting an icd or ipm (implantable pacemaker) in an hm3 patient, the device to be implanted should be placed in close proximity to the hm3 pump and the telemetry verified.If the patient received a heartmate 3 and has a previously implanted device that is found to be susceptible to programming interference, the manufacturer recommends replacing the icd device with one that is not prone to programming interference.The safety testing and classification section of the ifu states that if the hm3 lvas does cause interference to another device, the user is encouraged to try to correct the interference by reorienting or relocating the equipment, increase the separation between the equipment, connect the equipment to an outlet on a circuit different from that to which other devices are connected, or contact the manufacturer for assistance.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 13061590
• MDR Text Key: 282633496
• Report Number: 2916596-2021-07359
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106524
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other