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

Model Number 2088TC/58

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

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

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the patient's rv lead dislodged after implant.The patient underwent surgery on (b)(6) 2016 during which the lead was repositioned.However, the lead dislodged again as noted post procedure.Subsequently, the physician elected to explant and replace the lead on (b)(6) 2016.No patient symptoms were reported.The physician stated there was an unidentified material attached to the helix.

Manufacturer Narrative

(b)(4).A complete lead was returned.Visual inspection revealed the helix was partially extended and the steroid plug was found to be shifted towards the end of the helix.Without cleaning, the helix could be fully extended and retracted.The measured full helix extension length was within specification.Electrical testing did not find any indication of conductor fractures or internal shorts.The results of the investigation concluded the analysis of the device was normal, no anomalies were found.Based on the information received, the cause of the reported lead dislodgement and unspecified lead damage could not be conclusively determined.The shifted steroid plug was likely the material noted in the helix reported in the field.

• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6143543
• MDR Text Key: 61396772
• Report Number: 2017865-2016-07532
• 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: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• 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: 2088TC/58
• Device Lot Number: P000034277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2016
• 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