MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ALLURE RF; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3222

Device Problems Signal Artifact/Noise (1036); Connection Problem (2900)

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

Event Date 05/18/2017

Event Type  malfunction  

Event Description

During implantation procedure, noise was noted when the lead was connected to the header of the device, all electrical measurements were good connected to patient system analyzer (psa).Therefore, the device was exchanged and the patient was in stable condition.

Manufacturer Narrative

Analysis of the atrial, right ventricular, and left ventricular connectors on the device revealed no anomalies.Electrical testing showed no indication of conductor fractures or internal shorts.The results of the investigation concluded the analysis of the device was normal with no anomalies found.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: ALLURE RF
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6686333
• MDR Text Key: 79058733
• Report Number: 2017865-2017-05825
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 09/22/2017

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: 08/31/2018
• Device Model Number: PM3222
• Device Lot Number: A000035727
• Other Device ID Number: 05414734507905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2017
• Initial Date FDA Received: 07/05/2017
• Supplement Dates Manufacturer Received: 08/29/2017
• Supplement Dates FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR