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

Model Number CD2357-40Q

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problems Twiddlers Syndrome (2114); Discomfort (2330)

Event Date 10/21/2020

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: 2017865-2020-17544, 2017865-2020-17545.It was reported the patient presented to the emergency room with chest discomfort.Upon interrogation, it was observed the atrial and right ventricular lead impedances were varying and there was no capture.The atrial lead was also oversensing far p waves.A chest x-ray was completed to confirm both leads were dislodged and appeared to be braided together in the pocket.When prepping for revision procedure, it was observed the implantable cardioverter defibrillator was flipped in the pocket and there was a cracked pin on the ventricular lead.The ventricular lead was explanted and replaced, while the atrial lead and device remained implanted and active.The patient was stable.

• Brand Name: FORTIFY ASSURA DR ICD, 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: 10820661
• MDR Text Key: 215956890
• Report Number: 2017865-2020-17547
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734508094
• UDI-Public: 05414734508094
• 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: 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: 03/31/2022
• Device Model Number: CD2357-40Q
• Device Catalogue Number: CD2357-40Q
• Device Lot Number: A000095377
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 11/11/2020
• Supplement Dates FDA Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; TENDRIL MRI
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR