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

Model Number PM3222

Device Problems Over-Sensing (1438); High Capture Threshold (3266)

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

Event Date 09/27/2017

Event Type  Injury  

Event Description

It was reported that during the check at the hospital, high pacing thresholds and oversensing were noted.The patient was asymptomatic.The device was electively explanted and replaced with medtronic to address pacing issue.The patient was stable.

Manufacturer Narrative

The reported field event of high capture threshold and oversensing was not confirmed in the laboratory.The device was tested on the bench and no anomalies were found.

• Brand Name: ALLURE RF
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 6959792
• MDR Text Key: 89672336
• Report Number: 2938836-2017-33011
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: PM3222
• Device Lot Number: A000029623
• Other Device ID Number: 05414734507905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 55 YR