MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD2257-40Q FORTIFY ASSURA DR ICD_IDE_US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD2257-40Q
Medical Device Problem Codes	Failure to Capture (1081); Incorrect Measurement (1383); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 2017865-2022-12161.It was reported that a patient presented in-clinic for an explant procedure.Examination of the patient's implantable cardioverter defibrillator (icd)was found to have exhibited a diagnostic anomaly, as the device was not able to return a high voltage impedance reading.Additional malfunctions of low pacing impedance and loss of capture were noted on the device.The patient's right ventricular (rv) lead was found to have malfunctions of high capture thresholds and insulation break.The rv lead was capped and the icd was explanted on (b)(6) 2022.Both the icd and rv lead were replaced.No patient consequences were reported.
Additional Manufacturer Narrative
The reported event of capture anomaly and impedance anomaly could not be confirmed.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.A longevity calculation was performed and found the battery depletion was normal based on the device usage.

• Brand Name: CD2257-40Q FORTIFY ASSURA DR 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: 14683214
• Report Number: 2017865-2022-12162
• Device Sequence Number: 4675115
• Product Code: NVZ
• UDI-Device Identifier: 05414734505550
• UDI-Public: 05414734505550
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2022

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: 12/31/2014
• Device Model Number: CD2257-40Q
• Device Catalogue Number: CD2257-40Q
• Device Lot Number: 4132788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• 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: 05/24/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2013
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male