MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) RIATA ACTIVE FIXATION; DEFIBRILLATION LEAD

Model Number 1581/65

Device Problems Failure to Deliver Shock/Stimulation (1133); No Device Output (1435); Failure to Convert Rhythm (1540); Low impedance (2285)

Patient Problems Death (1802); Ventricular Fibrillation (2130)

Event Date 02/15/2020

Event Type  Death  

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.Patient's physician - (b)(6) cardiology - (b)(6).

Event Description

Related manufacturer report number: 2017865-2020-03311, 2017865-2020-03314.It was reported that the patient presented for a follow up in clinic on (b)(6) 2020 with no complaints.The patient¿s spouse reported the patient was not feeling very well days after.No specific symptoms were provided.The patient subsequently died on (b)(6), 2020.Review of the available data on (b)(6) 2020 revealed alerts on the fortify assura icd for ¿possible high voltage lead issue¿ and ¿possible high voltage circuit damage detected.¿ due to these alerts, therapy was not delivered.¿possible high voltage lead issue,¿ also known as an ocd (over current detection) safety check is an alert triggered when excess current is detected in the high voltage (hv) circuitry during hv charge and delivery into a low impedance load.¿possible high voltage circuit damage detected,¿ or shorted output stage detection (sosd)is an alert triggered when during a safety check, the device detects potential damage to a high voltage circuit during high voltage charging of the capacitors and aborts all subsequent requests for high voltage charging.¿high voltage lead impedance (hvli) was out of range¿ (< 10 ohms) or low was also noted.An episode from (b)(6) 2020 at 3:31 am notes the device delivered an 800 v shock, but this did not convert the ventricular fibrillation (vf).The impedance from this shock was < 10 ohms.The device then redetected the vf but because of the sosd alert, the device was unable to deliver additional therapy.The cause of death was noted by the physician to be ventricular fibrillation although a death certificate was not available.It was noted by the provider that atrial lead egms had revealed low atrial lead noise with some auto-mode switching but this was not considered a problem.The atrial chamber is not a life support/sustaining chamber.The device and leads were not available for lab analysis and remained in the deceased patient.Further testing was therefore not available.

• Brand Name: RIATA ACTIVE FIXATION
• Type of Device: DEFIBRILLATION LEAD
• 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 9824532
• MDR Text Key: 183137928
• Report Number: 2017865-2020-03312
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2008
• Device Model Number: 1581/65
• Device Lot Number: 0002212141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2005
• 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
• Treatment: FORTIFY ASSURA DR ICD; TENDRIL SDX LEAD
• Patient Outcome(s): Death
• Patient Age: 72 YR