MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUICKSITE LV; PERMANENT PACEMAKER ELECTRODE

Model Number 1056T/75

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 02/23/2023

Event Type  malfunction  

Event Description

This report is to advise of an event observed during analysis.

Manufacturer Narrative

No complaint was received with the return of the lead.A failure event was observed during analysis.A partial lead was returned in three pieces.Connection portion (a) measured 5.5/10.5cm (insulation/stretched inner coil).Middle portion (b) measured 5.0/8.1/8.6/18.7cm (insulation/cables/ptfe liner/stretched inner coil) while distal portion (c) measured 63.0.Visual examination of the lead found an internal abrasion in portion (c) breaching the ring electrode lumen and exposing the cables at 5.6cm to 7.2cm from the distal tip.The etfe cable coating and inner lumen were intact.Ptfe - polytetrafluoroethylene.Etfe - ethylene tetrafluoroethylene.

• Brand Name: QUICKSITE LV
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16449144
• MDR Text Key: 310331884
• Report Number: 2017865-2023-11013
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2009
• Device Model Number: 1056T/75
• Device Lot Number: 0002118440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1482-2012
• Patient Sequence Number: 1