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

Model Number 1056T/86

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

No complaint was received with return of the device.Failure event observed during analysis.Final analysis found only the distal portion was returned in one piece measuring 70.4 cm.Internal insulation abrasion breaching the ring electrode (re) lumen was noted at 5.0 ¿ 5.5 cm from the distal tip.The etfe coating of the re cable was intact in this region.Other damages found were consistent with surgical damage.

Event Description

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

• 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 9959722
• MDR Text Key: 187617533
• Report Number: 2017865-2020-05023
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2008
• Device Model Number: 1056T/86
• Device Lot Number: 0002118005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2005
• 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