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

Model Number PM3222

Device Problems Signal Artifact/Noise (1036); Difficult to Interrogate (1331); Pacing Intermittently (1443)

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

Event Date 08/03/2017

Event Type  Injury  

Event Description

Related manufacturer report number: 2017865-2017-31367.During a follow-up, there were episodes of noise on the right ventricular (rv) channel.There were also episodes of inhibited pacing due to the noise episodes.While attempting to reprogram the device, it was difficult to interrogate and reprogram the device.The lead and the device were explanted and replaced and the patient was stable.

Manufacturer Narrative

Additional information: the device was received for evaluation and the device image showed about two hours of high power usage.Telemetry issue noted in the field is consistent with device normally switching to 8k telemetry mode, due to excessive high power usage, in order to preserve battery power.Analysis was performed; including thermal and mechanical revealed no anomalies.Visual inspection of septum, setscrew, and contact spring did not reveal any anomaly that could contribute to noise.Further analysis was performed to test for crosstalk and output monitoring indicated normal device performance.

• 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: 6827639
• MDR Text Key: 83886931
• Report Number: 2017865-2017-31366
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: PM3222
• Device Lot Number: A000031722
• Other Device ID Number: 05414734507905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2016
• 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
• Treatment: TENDRIL STS (SN (B)(4))
• Patient Outcome(s): Hospitalization; Required Intervention