MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY DR, U1.6 DF1 US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD2231-40

Device Problems Energy Output Problem (1431); Over-Sensing (1438)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2020

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: 2017865-2020-14739.It was reported the asymptomatic patient presented for an unrelated procedure.Upon device check, it was observed the right ventricular lead had low lead impedance and oversensing episodes with pacing inhibition.The implantable cardioverter defibrillator had over current detection alerts, oversensing with pacing inhibition, and shorted output stage detection episodes.The lead was capped and replaced on (b)(6) 2020 and a new device implanted.The patient was stable.

Manufacturer Narrative

The analysis indicated the cause of the damage was high voltage delivery into a low impedance load.This low impedance load is consistent with a lead-to-can arc and, therefore, is not considered a device malfunction.Interrogation of the device revealed that the device was at elective replacement indicator and in bvvi (backup vvi) when received.Review of the device image showed that the device entered backup vvi mode on sep 14, 2020 due to a por (power on reset).The cause of the por (power on reset) is also consistent with a lead-to-can arc and, therefore, is also not considered a device malfunction.All low voltage device functions were normal.

• Brand Name: FORTIFY DR, U1.6 DF1 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: 10623943
• MDR Text Key: 209743983
• Report Number: 2017865-2020-14740
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734504379
• UDI-Public: 05414734504379
• 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: 12/28/2020

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: 09/30/2013
• Device Model Number: CD2231-40
• Device Catalogue Number: CD2231-40
• Device Lot Number: 3660151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 12/23/2020
• Supplement Dates FDA Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RIATA ACTIVE FIXATION
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR