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

Model Number 2088TC/58

Device Problems Break (1069); Low impedance (2285); Device Sensing Problem (2917); Device Contamination with Chemical or Other Material (2944); Unstable Capture Threshold (3269)

Patient Problems Hematoma (1884); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

During a lead replacement procedure, the physician noticed blood inside the lead insulation.The lead was explanted.The patient was stable.Additional information was requested but not received.

Event Description

Related mfr number: 2017865-2017-31418.Additional information received revealed capture, sensing, and low impedance issues were observed on the right ventricular (rv) lead, and capture and sensing issue were observed on the device.The rv lead and the device were explanted and replaced and the patient was stable.

Manufacturer Narrative

Upon analysis a complete lead was returned in one piece.Electrical testing did not reveal any indication of conductor fractures.Visual examination revealed explant damage at the middle region of the lead.The lead failed in hi-pot and arching of current was noted in this region.Destructive analysis was performed and revealed damaged inner insulation.The damage found could have caused blood to gain access throughout the lead lumen.All the damages found are consistent with procedural damage.

Event Description

During follow-up, capture, sensing, and low impedance issues were observed on the right ventricular (rv) lead, and capture and sensing issues were observed on the device.The rv lead was explanted and replaced and the patient was stable.A hematoma was noted at the pocket site which resulted in a discontinuation of anti-coagulation medication.Additional information was requested but not yet received.

• 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: 6687847
• MDR Text Key: 79121758
• Report Number: 2017865-2017-05875
• 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,Followup,Followup
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 2088TC/58
• Device Lot Number: P000041666
• Other Device ID Number: 05414734502894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2017
• 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): Hospitalization; Required Intervention