MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. TENDRIL STS; PERMANENT PACEMAKER ELECTRODE

Model Number 2088TC/52

Device Problems Device Dislodged or Dislocated (2923); Device Contamination with Chemical or Other Material (2944); Positioning Problem (3009)

Patient Problem Dyspnea (1816)

Event Date 02/25/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient was rehospitalized due to dyspnea 11 days after being implanted with the atrial lead.The cardiologist found that the lead had dislodged from the right atrial cardiac wall.A revision was scheduled but during the procedure the lead could not be reattached, so it was explanted and replaced.The cardiologist noted that there was foreign material on the helix of the lead which may have prevented the helix from correctly attaching to the cardiac wall.

Manufacturer Narrative

Upon analysis, the field reports of lead dislodgement, silicon material at the distal end of the helix, and inability to reposition lead were not confirmed.The steroid plug was not returned with the lead.The helix extension length was measured to be within specification as returned and electrical testing found no indication of conductor fractures or internal shorts.Visual inspection of the lead revealed no anomalies.

• Brand Name: TENDRIL STS
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6394759
• MDR Text Key: 69584644
• Report Number: 2017865-2017-01353
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P960013
• 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: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 2088TC/52
• Device Lot Number: P000038893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2016
• 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