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

Model Number 1458Q/86

Device Problems Signal Artifact/Noise (1036); Break (1069); Over-Sensing (1438)

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

Event Date 10/22/2018

Event Type  Injury  

Event Description

During a follow-up in clinic, there was noise noted on the right ventricular (rv) and left ventricular (lv) leads due to suspected subclavian crush syndrome.The noise was reproducible in clinic during lead provocative testing.Both leads were explanted and replaced and the patient was stable with no consequences.Related manufacturer report number: 2017865-2018-16429.

Manufacturer Narrative

Additional information: as received, a complete lead was returned in one piece.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual inspection of the lead did not find any anomalies except for damages consistent with procedural damage.The reported events of noise and insulation abrasion were not confirmed.

• 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: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8031468
• MDR Text Key: 125900102
• Report Number: 2017865-2018-16430
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 1458Q/86
• Device Lot Number: A000029211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2016
• 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): Hospitalization; Required Intervention