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

Model Number 1458Q/86

Device Problems Failure to Capture (1081); Loose or Intermittent Connection (1371)

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

Event Date 11/24/2017

Event Type  malfunction  

Event Description

During implant, the lead was not able to be screwed fully into the header of the device, leading to inadequate capture.A different lead was used to resolve the event and the patient's condition was stable following the procedure.

Manufacturer Narrative

The reported events of a capture issue and the connector being too loose were not confirmed.As received, a complete lead was returned in one piece for analysis.Visual inspection of the lead did not find any anomalies at the connector region or throughout lead body.Dimensional analysis revealed the diameters of the is-4 connector pin, connector ring electrodes, and the connector seal zones to be within specification.An insertion test was performed with a test device and no anomalies were noted.Electrical tests that could be performed on the returned portion of the lead did not find any conductor fractures or internal shorts.

• 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: 7151189
• MDR Text Key: 95937616
• Report Number: 2017865-2017-36617
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 02/05/2018

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: 08/31/2020
• Device Model Number: 1458Q/86
• Device Lot Number: S000040875
• Other Device ID Number: 05414734503198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 01/19/2018
• Supplement Dates FDA Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2017
• 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