MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. RIATA ST PASSIVE FIXATION; DEFIBRILLATION LEAD

Model Number 7042/65

Device Problems Unexpected Therapeutic Results (1631); Protective Measures Problem (3015)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 07/17/2017

Event Type  malfunction  

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.

Event Description

Upon device interrogation, an alert was identified which indicated over current detection (ocd) occurred while the device was delivering high voltage therapy due to a possible lead right ventricular lead issue.The patient¿s high voltage therapy was inhibited inappropriately as a protective measure due to the ocd.There has been no action taken at this time and the patient was stable with no consequences.

• Brand Name: RIATA ST PASSIVE FIXATION
• Type of Device: DEFIBRILLATION LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6799111
• MDR Text Key: 82868975
• Report Number: 2938836-2017-31115
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/16/2017

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: 03/31/2013
• Device Model Number: 7042/65
• Device Lot Number: 3097726
• Other Device ID Number: 05414734501088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2017
• Initial Date FDA Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2010
• 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