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

Model Number	CD1257-40
Medical Device Problem Codes	High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Failure to Sense (1559); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient presented remotely via merlin.Net.Upon examination of the transmission, the patient's implantable cardioverter defibrillator was found to have exhibited over-sensing of noise, inappropriate shock, high defibrillation impedance, failure to sense, and an output rate issue.No intervention was reported.The patient was in unknown condition.
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
Related manufacturer reference number: 2017865-2022-09334 it was reported that a patient presented remotely via merlin.Net.Upon examination of the transmission, the patient's implantable cardioverter defibrillator was found to have exhibited over-sensing of noise, inappropriate shock, high defibrillation impedance, failure to sense, and an output rate issue.Additionally, the patient's right ventricular (rv) lead was found to have exhibited over-sensing of noise without any additional malfunction.No intervention was reported.The patient was in unknown condition.
Additional Manufacturer Narrative
Correction: h10 additional information: b5: related manufacturer's number needed to address new information of additional related report.Correction: b5: summary of event include information reported in report number : 2017865-2022-09334.

• Brand Name: FORTIFY ASSURA VR ICD_IDE_US
• Common Device Name: 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 14015453
• Report Number: 2017865-2022-07118
• Device Sequence Number: 11901859
• Product Code: NVZ
• UDI-Device Identifier: 05414734505468
• UDI-Public: 05414734505468
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: CD1257-40
• Device Catalogue Number: CD1257-40
• Device Lot Number: 4000922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RIATA; TENDRIL SDX; TENDRIL SDX
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Female