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

Model Number CD2231-40Q

Device Problem No Device Output (1435)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2019

Event Type  malfunction  

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

Event Description

It was reported that during the device change procedure the implantable cardioverter defibrillator exhibited a loss of pacing output.The patient was pacemaker dependent therefore the device was programmed to do prior to the procedure; however exposure to electrocautery caused the inhibition of the pacing function.The device was successfully explanted and replaced.The patient was stable.

Manufacturer Narrative

Interrogation of the device revealed the device was at elective replacement indicator (eri) when received.A longevity calculation was performed based upon programmed settings and usage data.The calculations showed the battery depletion was normal.A device evaluation was performed, and no sources of high current were noted.The telemetry, pacing, sensing, impedance, hv output, hv shock, and patient notifier were tested on the bench.No anomaly was detected.The pacing output issue observed in the field was believed to be due to electrocautery exposure during explant procedure.

• Brand Name: FORTIFY DR, 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 9153891
• MDR Text Key: 161220142
• Report Number: 2017865-2019-14074
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734504386
• UDI-Public: 05414734504386
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• 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: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2012
• Device Model Number: CD2231-40Q
• Device Lot Number: 3221285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: 12/21/2019
• Supplement Dates FDA Received: 12/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2010
• 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 Age: 85 YR
• Patient Weight: 99