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

Model Number	1580/65
Medical Device Problem Codes	Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced inappropriate shock from the right ventricular lead after episodes of atrial fibrillation with rapid ventricular response were observed.The physician suspected that this was caused by a right ventricular lead failure.On (b)(6) 2021, the lead was successfully explanted and replaced.There were no other adverse patient consequences noted.
Additional Manufacturer Narrative
The reported event of inappropriate shock and oversensing were not confirmed.During analysis, a failure event was observed which was unrelated to the reported event.Final analysis found the complete lead was received in one piece measuring 64.8 cm.An external insulation abrasion breaching the right ventricular (rv) cable lumen was noted at 32.9 cm to 33.1 cm from the connector pin.The external insulation abrasion damage was consistent with friction to another implanted device or feature of the patient anatomy.Internal insulation abrasions breaching the ring electrode (re) cable lumen were noted at 23.6 cm to 24.4 cm, 33.0 cm to 36.9 cm, 51.2 cm to 54.8 cm, and 55.4 cm to 56.6 cm from the connector pin.Internal insulation abrasions breaching the superior vena cava (svc) cable lumen were noted at 21.7 cm to 22.8 cm and 33.0 to 36.9 cm from the connector pin.The internal insulation abrasions were proximal and in between the svc shock coil.

• Brand Name: RIATA ACTIVE FIXATION
• Common Device Name: 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 12813969
• Report Number: 2017865-2021-36719
• Device Sequence Number: 17332547
• Product Code: NVY
• UDI-Device Identifier: 05414734506106
• UDI-Public: 05414734506106
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2021

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: 03/31/2007
• Device Model Number: 1580/65
• Device Catalogue Number: CD1311-36
• Device Lot Number: 0002193126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• 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: 10/25/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2004
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0457-2012
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELLIPSE VR
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 178 KG