MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY ASSURA CRT-D RF HV; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3357-40C

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Under-Sensing (1661)

Patient Problems Syncope (1610); Fall (1848); Hip Fracture (2349)

Event Date 09/02/2020

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the patient experienced syncope, fell, and broke his hip and presented to the emergency room.Upon examination, it was found that the implantable cardioverter defibrillator had noise oversensing on all three lead channels that resulted in pacing inhibition.It was suspected that the oversensing may have been caused by electromagnetic interference (emi).The patient was asked if he was exposed to any possible electromagnetic interference at home.However, he could not recall being near any possible source of electrical equipment or power source.The device therapy was then turned off and was programmed to pace in the ventricle only in preparation for his hip repair surgery.Subsequently, the patient had a successful hip repair surgery and the device therapy was turned on again.It was also noted that the right ventricular lead impedance had slowly been rising over the years.No other intervention was performed at this time.It was reported that the patient remained in stable condition while recovering at the hospital.Related manufacturer reference number: 2017865-2020-14037, 2017865-2020-14038, 2017865-2020-14039.

Manufacturer Narrative

The implantable cardioverter defibrillator system did not exhibit episodes of undersensing.The previous report should have stated that there were noise oversensing episodes prior to the patient's fall.

Manufacturer Narrative

Additional information: b5 and h6 device code.

Event Description

New information received stated that prior to the patient's fall, the device and leads also exhibited undersensing.It was then noted that right ventricular lead impedance continued to increase slowly.On oct.20th, 2020, the right ventricular lead was capped and replaced without any complications.The patient's condition remained stable after the procedure.

• Brand Name: UNIFY ASSURA CRT-D RF HV
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10570639
• MDR Text Key: 208085389
• Report Number: 2017865-2020-14036
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508186
• UDI-Public: 05414734508186
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2020

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: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: CD3357-40C
• Device Catalogue Number: CD3357-40C
• Device Lot Number: A000060288
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 10/16/2020; 11/06/2020
• Supplement Dates FDA Received: 11/05/2020; 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: QUICKSITE; RIATA; TENDRIL SDX
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 66