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 Break (1069)

Patient Problem Twiddlers Syndrome (2114)

Event Date 09/07/2017

Event Type  Injury  

Event Description

It was reported that the asymptomatic patient presented in clinic on (b)(6) 2017.Upon interrogation of the pulse generator, loss of capture was noticed on the right ventricular lead.During the device check prior to procedure to reposition the lead on (b)(6) 2017, loss of capture was also observed on the left ventricular lead.A chest x-ray confirmed both leads were dislodged due to the patient having twiddler¿s syndrome.The patient was asymptomatic to the dislodgement and the loss of capture.The leads were explanted and replaced.During the procedure, the physician attempted to connect the pulse generator to the new right ventricular lead, but was unable to as the header to the pulse generator appeared to be damaged.The pulse generator was explanted and replaced.The patient was fine post procedure.

Manufacturer Narrative

The reported field event of the right ventricular lead could not be inserted was not confirmed in the laboratory.The device was tested on the bench and no anomalies were found.Normal device characteristics 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: 7001286
• MDR Text Key: 91050402
• Report Number: 2017865-2017-34123
• 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: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: PM3262
• Device Lot Number: A000027894
• Other Device ID Number: 05414734509091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2016
• 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: 63 YR