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

Model Number 2088TC/52

Device Problems Failure to Capture (1081); Difficult To Position (1467); Device Dislodged or Dislocated (2923); Device Contamination with Chemical or Other Material (2944)

Patient Problem Muscle Stimulation (1412)

Event Date 02/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient had presented to the hospital experiencing pocket stimulation.A loss of capture was observed on the atrial lead.It was determined that the lead had become dislodged.It was noted that the patient had experienced trauma at the site of implant.The lead was programmed off until a revision procedure was performed.During the procedure, a white material was observed on the lead's helix, preventing repositioning.The lead was explanted and replaced.The patient was noted to be in good condition following the procedure and would be monitored through follow-up.

Manufacturer Narrative

(b)(4).

Event Description

New information reported that the patient had fallen, which resulted in the lead dislodgement.A loss of sensing was also observed.

• Brand Name: TENDRIL STS
• 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: 5429274
• MDR Text Key: 37960880
• Report Number: 2017865-2016-00864
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: 2088TC/52
• Device Lot Number: 4802612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2016
• Initial Date FDA Received: 02/10/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/23/2016; 03/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2014
• 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
• Patient Age: 48 YR