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

Model Number PM3262

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bradycardia (1751); Twiddlers Syndrome (2114)

Event Date 11/10/2017

Event Type  malfunction  

Manufacturer Narrative

No code available for slow communication due to rf lockout.

Event Description

It was reported that the patient presented in the emergency room in bradycardia with no symptoms.Upon interrogation the atrial, right ventricular and left ventricular leads were noted to be dislodged which was confirmed on x-ray.The patient was suspected to have twiddler¿s syndrome.During the procedure the atrial and the right ventricular lead could not be extended and retracted.Guidewire could not be inserted down the left ventricular lead.All the three leads were explanted.The patient became dependent and the device was found to be in rf lockout.The device was explanted since the communication was slow.The patient was stable post procedure.

Manufacturer Narrative

Device was returned for non-functional rf telemetry and slow communication response during leads replacement procedure.The device image analysis indicated that the rf telemetry lockout was seen due to excessive rf usage in a short period of time.The device was tested on the bench and no anomalies were found.

• 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: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7060948
• MDR Text Key: 93080902
• Report Number: 2017865-2017-35042
• 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,Followup
• Report Date: 01/23/2018

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: 01/31/2019
• Device Model Number: PM3262
• Device Lot Number: A000042900
• Other Device ID Number: 05414734509091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2017
• Initial Date FDA Received: 11/27/2017
• Supplement Dates Manufacturer Received: 01/20/2018
• Supplement Dates FDA Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2017
• 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 Age: 86 YR