MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ALLURE RF; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3222

Device Problem High Capture Threshold (3266)

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

Event Date 05/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during the implant procedure, the pulse generator exhibited high capture thresholds on the left ventricular channel.The device was not used and a new device was implanted.No patient symptoms were reported.

• Brand Name: ALLURE RF
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• 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: jaime chavez ; 15900 valley view court; sylmar, CA 91342 ; 8184934022
• MDR Report Key: 5740431
• MDR Text Key: 47904691
• Report Number: 2017865-2016-03889
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• PMA/PMN Number: P970013
• 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: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: PM3222
• Device Lot Number: A000017681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2016
• 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
• Patient Age: 63 YR