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

Model Number PM3242

Device Problems Over-Sensing (1438); Connection Problem (2900)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient remotely via merlin.Net and oversensing was noted which caused pacing inhibition and the patient symptomatic.On (b)(6) 2016 the device was explanted and replaced.It was suspected that the device header had contributed to the intermittent noise in both channels.The patient was doing well post surgery and would continue to be monitored.

Event Description

New information reported stated that on (b)(6) 2016 a merlin.Net transmission revealed noise on both the atrial and ventricular channels.It was suspected that the noise was due to the leads.

• Brand Name: ALLURE QUADRA 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: jaime chavez ; 15900 valley view court; sylmar, CA 91342 ; 8184934022
• MDR Report Key: 6038598
• MDR Text Key: 57773980
• Report Number: 2017865-2016-06641
• 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: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: PM3242
• Device Lot Number: A000014955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2016
• Initial Date FDA Received: 10/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2015
• 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: 19 YR