MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Discomfort (2330)

Event Date 06/06/2016

Event Type  Injury  

Event Description

It was reported that the patient had a generator replacement on (b)(6) 2016.Migration of the device was mentioned as a reason for replacement stating that it moved inferiorly and caused discomfort which also contributed to the decision to replace the device.The physician¿s office noted that the migration was first documented on (b)(6) 2016.The explanted device is not retrievable from the explanting facility and was discarded.No additional information has been received to date.

Event Description

Operative notes were received from the patient¿s generator implantation surgery on (b)(6) 2011.The notes indicated that the surgeon used an absorbable suture to close the subcutaneous layers of tissue.The notes did not indicate whether the generator was anchored to the tissue with a suture.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6118483
• MDR Text Key: 60571983
• Report Number: 1644487-2016-02698
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2012
• Device Model Number: 103
• Device Lot Number: 2839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2010
• 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: 59 YR