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

Model Number 1580/65

Device Problem Failure to Conduct (1114)

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

Event Date 05/29/2015

Event Type  malfunction  

Event Description

It was reported that during device change-out due to normal eri, externalized conductors were observed under fluoroscopy.No patient symptoms were reported.No electrical anomalies were detected.The lead was capped and replaced.The patient was stable and will continue to be monitored normally.

Manufacturer Narrative

(b)(4).

• Brand Name: RIATA ACTIVE FIXATION
• Type of Device: DEFIBRILLATION LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: jaime chavez ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184934022
• MDR Report Key: 4854923
• MDR Text Key: 21766965
• Report Number: 2938836-2015-27248
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2004
• Device Model Number: 1580/65
• Device Lot Number: 0002432707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2002
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z0457
• Patient Sequence Number: 1
• Patient Age: 68 YR