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 02/20/2020

Event Type  malfunction  

Manufacturer Narrative

No complaint was received with the return of the device.Failure event observed during analysis.Final analysis found that a complete lead was returned in two pieces: the connector portion measured 22.0 cm while the distal portion measured 64.0 cm.Dissection beneath the lead insulation at the s-curve region found internal insulation abrasion breaching between ring electrode cable and inner coil lumens at 4.0 -5.0 cm from distal tip.The etfe cable coating was found to be intact in this location.Abbott is continuing to monitor this issue.

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: 9814445
• MDR Text Key: 182962896
• Report Number: 2017865-2020-03376
• 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: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2010
• Device Model Number: 1056T/86
• Device Lot Number: 0002115128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2007
• 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