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

Model Number CD2257-40Q

Device Problems Difficult to Interrogate (1331); Battery Problem (2885); Inappropriate or Unexpected Reset (2959)

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

Event Date 03/23/2019

Event Type  Injury  

Event Description

Following the battery performance alert (bpa) advisory, a bpa was received by the clinician and the device was explanted.Prior to the explant procedure, the physician had difficulty interrogating the device.Upon review, the device found to be in backup vvi mode.Subsequently, the device was explanted and replaced.The patient was stable before, during, and after the procedure.

• Brand Name: CD2257-40Q FORTIFY ASSURA DR ICD_IDE_US
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8485188
• MDR Text Key: 141007184
• Report Number: 2938836-2019-02468
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734505550
• UDI-Public: 05414734505550
• 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: Nurse
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/04/2019

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: 10/31/2013
• Device Model Number: CD2257-40Q
• Device Lot Number: 3693737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2019
• Initial Date FDA Received: 04/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0003-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability