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

Model Number 7000/65

Device Problems Failure to Capture (1081); No Device Output (1435); High Capture Threshold (3266)

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

Event Date 07/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported when a patient presented to the clinic for a follow-up, interrogation revealed a dramatic increase in threshold and ventricular oversensing.Lead damage was suspected.It was noted the morphology template was not giving accurate template variables.Several of the backup pulses delivered to cover for uncaptured paces were not captured themselves.There were also instances when the device did not detect loss of capture and failed to deliver a backup pulse.Review of session records indicated the patient may have experienced a sensing event in the atrium.The lead was capped and replaced.The patient condition was stable during and throughout the procedure.

Manufacturer Narrative

The lead exhibited normal electrical characteristics.

• Brand Name: RIATA ST 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: 5901695
• MDR Text Key: 52940474
• Report Number: 2938836-2016-10547
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2010
• Device Model Number: 7000/65
• Device Lot Number: 2979045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/09/2007
• 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