MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY VR, U1.6 SJ4 US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD1231-40Q

Device Problems Energy Output Problem (1431); Inappropriate or Unexpected Reset (2959)

Patient Problem Arrhythmia (1721)

Event Date 10/17/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number:2017865-2020-17264.It was reported that the patient presented to the emergency room after receiving three successful shocks for ventricular tachycardia.Device interrogation revealed alerts for a shorted output stage and over current detection.Defibrillation impedance measured below the lower limit.The patient was admitted to the hospital.While awaiting device replacement the patient experienced a slow ventricular tachycardia episode; however, the device was found in backup operation and the patient required external defibrillation.The device was able to be programmed to an appropriate pacing rate.During the replacement procedure the lead was found to have worn insulation where it was coiled under the can.On (b)(6) 2020 the device was explanted and right ventricular lead was capped and replaced.There were no further patient consequences.

Manufacturer Narrative

The reported events ocd (over current detection) and sosd (shorted output state detection) were both confirmed.The analysis indicated that there was damage to the high voltage output circuitry of the device.The cause of the damage was high voltage delivery into a low impedance load.This low impedance is consistent with a lead-to-can arc and, therefore, is not considered a device malfunction.The reported event of reset was confirmed by analysis.The cause of the reset was found to be due to a por (power on reset).The cause of the por is consistent with external defibrillation and, therefore, is also not considered a device malfunction.Interrogation of the device revealed that the device was above elective replacement indicator when received.All low voltage device functions were normal.

• Brand Name: FORTIFY VR, U1.6 SJ4 US
• 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: 10796607
• MDR Text Key: 214996033
• Report Number: 2017865-2020-17259
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734504348
• UDI-Public: 05414734504348
• Combination Product (y/n): N
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

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: 04/30/2012
• Device Model Number: CD1231-40Q
• Device Catalogue Number: CD1231-40Q
• Device Lot Number: 3245180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR; DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 79