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

Model Number LPA1200M/58

Device Problems Failure to Capture (1081); Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/01/2017

Event Type  Injury  

Event Description

It was reported that the patient presented in clinic for follow up.Upon interrogation, the right atrial lead exhibited loss of capture.On (b)(6)2017, the patient presented for lead revision.During procedure, the lead could not be repositioned.Physician noted silicon cover on the helix.The lead was explanted and replaced successfully.The patient experienced no adverse consequences throughout the event.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• Brand Name: TENDRIL MRI
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6455375
• MDR Text Key: 71575621
• Report Number: 2017865-2017-02020
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: LPA1200M/58
• Device Lot Number: S000024504
• Other Device ID Number: 05414734504638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2016
• 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
• Patient Outcome(s): Required Intervention