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

Model Number	1581/65
Medical Device Problem Codes	High impedance (1291); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented in clinic for follow up.Upon review, the right ventricular lead exhibited high pacing and defibrillation impedance.Fluoroscopy imaging showed that the lead had externalized conductors.The lead was capped and replaced on (b)(6) 2022.The patient condition was stable post-procedure.
Additional Manufacturer Narrative
The reported events of insulation abrasion, high defibrillation lead impedance and high pacing lead impedance could not be confirmed.As received, only the connector segment of the lead was returned in one piece.Electrical testing and x-ray examination did not find any indication of conductor fractures or internal shorts.Visual inspection of the lead did not find any anomalies except for the cut end which is consistent with procedural damage.
Additional Manufacturer Narrative
Correction: b5 was updated.
Event or Problem Description
It was reported that the patient presented in clinic for follow up.Upon review, the right ventricular lead exhibited high pacing and defibrillation impedance.Fluoroscopy imaging showed that the lead had externalized conductors.The lead was explanted and replaced.The patient condition was stable post-procedure.

• 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: 15027427
• Report Number: 2017865-2022-15235
• Device Sequence Number: 4583668
• Product Code: NVY
• UDI-Device Identifier: 05414734506106
• UDI-Public: 05414734506106
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2022

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: 04/30/2009
• Device Model Number: 1581/65
• Device Catalogue Number: CD1311-36
• Device Lot Number: 0002110364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/06/2022
• Supplement Date Received by Manufacturer: 08/04/2022; 08/29/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 08/09/2022; 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2006
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 93 KG