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

Model Number PM3262

Device Problems Pacemaker Found in Back-Up Mode (1440); Telemetry Discrepancy (1629); Operating System Version or Upgrade Problem (2997)

Patient Problems Undesired Nerve Stimulation (1980); Discomfort (2330)

Event Date 09/01/2017

Event Type  malfunction  

Event Description

It was reported that the patient presented in the emergency room experiencing phrenic nerve stimulation (pns) and discomfort.Upon interrogation, the patient's pacemaker was found in back-up vvi.An attempt to download a device restore from the engineering test page with the telemetry wand in several positions failed.The patient was sent home with the device still in back-up vvi and was told to stay in a position that minimized the pns.On (b)(6) 2017 attempts to restore the device with a different programmer failed.On (b)(6) 2017, the patient was brought to a different clinic, and with a different programmer, the device was successfully restored to original programming with no further pns.The patient was sent home in stable condition.

• Brand Name: QUADRA ALLURE MP RF CRT-P
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6926793
• MDR Text Key: 89713685
• Report Number: 2017865-2017-32250
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• 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
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: PM3262
• Device Lot Number: A000039088
• Other Device ID Number: 05414734509091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2017
• 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: 69 YR