MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY VR, U1.6 DF1 US; Pulse generator, permanent, implantable

Model Number CD1231-40

Device Problems Premature Discharge of Battery (1057); Charging Problem (2892)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2023

Event Type  malfunction  

Event Description

Related manufacturer report #: 2017865-2023-47323.It was reported that three episodes of ventricular fibrillation (vf) noted to be right ventricular (rv) lead noise were observed on electrocardiogram (ecg).Inappropriate therapy was not delivered due to the noise terminating before shock.The physician also observed a battery performance alert (bpa) with alerts for charge time but no elective replacement indicator (eri) alert.Since the patient's initial implant in 1994 due to a ventricular fibrillation arrest, the patient had no documented ventricular arrhythmias therefore the physician and patient elected to forgo generator and lead replacement.Future attempt at explant was unknown at this time.The physician deactivated tachycardia therapy.The patient was not being monitored remotely.The patient was stable.

Manufacturer Narrative

The device is included in the battery performance alert advisory issued by abbott on 28 august 2017.

• Brand Name: FORTIFY VR, U1.6 DF1 US
• Type of Device: Pulse generator, permanent, implantable
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17840872
• MDR Text Key: 324561831
• Report Number: 2017865-2023-47322
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734504355
• UDI-Public: 05414734504355
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/28/2023

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: 04/30/2013
• Device Model Number: CD1231-40
• Device Lot Number: 3580900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2011
• 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 Age: 61 YR
• Patient Sex: Male