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

Model Number 1581/65

Device Problems No Device Output (1435); Over-Sensing (1438); Decreased Sensitivity (2534)

Patient Problem Ventricular Tachycardia (2132)

Event Date 12/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported when the patient presented to the clinic, interrogation revealed an alert for possible output circuit damage and the device was found in reset mode since last year.Therapy had not been delivered due to possible output circuit damage and device reset.Some misclassified ventricular tachycardia episodes indicated lead noise.A decline in pacing lead impedance was observed.System replacement was recommended.The patient was kept at the nursing home and is in stable condition.No further information is available.

• 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: 5586840
• MDR Text Key: 42999587
• Report Number: 2938836-2016-02910
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2007
• Device Model Number: 1581/65
• Device Lot Number: 0002214041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2004
• 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: V-168 467030