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

Model Number 1882TC/46

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 12/23/2015

Event Type  malfunction  

Manufacturer Narrative

No complaint was received with return of the device.Failure event observed during analysis.Final analysis found that the insulation was abraded at 12.5 cm to 12.9 cm from the connector pin which exposed the outer coil.The abrasions were consistent with exposure to constant friction against another implantable device.(b)(4).

Event Description

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

Manufacturer Narrative

(b)(4).

• Brand Name: TENDRIL ST
• 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: jaime chavez ; 15900 valley view court; sylmar, CA 91342 ; 8184934022
• MDR Report Key: 5405386
• MDR Text Key: 37348763
• Report Number: 2017865-2016-00652
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• PMA/PMN Number: P960013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/13/2010
• Device Model Number: 1882TC/46
• Device Lot Number: 0002136181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2015
• Date Manufacturer Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR