MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/86

Device Problems Fracture (1260); High impedance (1291); No Pacing (3268)

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

Event Date 03/14/2017

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer report number: 2017865-2017-02228.There was high impedance with no pacing on the right atrial (ra) and left ventricular (lv) leads due to conductor fractures.Both leads were explanted and replaced and the patient was stable.

Manufacturer Narrative

As received, a partial lead (connector end) was returned for evaluation in one piece.Visual inspection of the lead revealed a breach of all the lumens, fracturing all the cables and all four filars of the inner coil distal to the suture sleeve tie impression.The cause of the reported events was consistent with clavicle crush.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: 6486950
• MDR Text Key: 72600700
• Report Number: 2017865-2017-02227
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030054
• 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: 01/30/2019

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: 05/31/2018
• Device Model Number: 1458Q/86
• Device Lot Number: A000007803
• Other Device ID Number: 05414734503198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2017
• Initial Date FDA Received: 04/12/2017
• Supplement Dates Manufacturer Received: 01/18/2019
• Supplement Dates FDA Received: 01/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2015
• 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
• Treatment: TENDRIL STS (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention