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

Model Number CD2357-40C

Device Problems Difficult to Interrogate (1331); Telemetry Discrepancy (1629)

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

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that it was unable to read the patient¿s device with an rf merlin at home transmitter and have overnighted the patient an inductive merlin at home transmitter to use temporarily.The cause of the problem was determined to be loss of rf telemetry.Patient will be scheduled to come into the clinic until (b)(6) of 2020.Patient will continue to use the inductive unit until patient returns to the clinic and the rf telemetry will be restored.

Event Description

New information notes that the patient condition was stable before, during, and after this instance.

• Brand Name: FORTIFY ASSURA DR ICD, 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: 9143397
• MDR Text Key: 160838950
• Report Number: 2938836-2019-14253
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734508063
• UDI-Public: 05414734508063
• 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,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: CD2357-40C
• Device Lot Number: 4330637
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 10/01/2019
• Supplement Dates FDA Received: 10/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1