MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Discomfort (2330)

Event Date 11/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported on (b)(6) 2016 that the patient was recently implanted but now her generator is reported to be moving around a lot in her chest.The movement is uncomfortable and it pinches her skin.Diagnostics were checked and were stated to be ok.No further information has been received to date.

Manufacturer Narrative

Outcomes attributed to adverse event, corrected data, initial mdr inadvertently omitted the selected of the outcome for the adverse event "required intervention to prevent permanent impairment/damage".

Event Description

Follow-up with the patient's surgeon was performed and it was reported that no trauma/manipulation occurred that may have caused the migration.Additionally, a non-absorbable suture was not used during implant of the generator.The patient had reportedly undergone a repositioning surgery for the discomfort from the migration.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 6166212
• MDR Text Key: 62122769
• Report Number: 1644487-2016-02838
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/29/2017
• Device Model Number: 106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2016
• 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
• Patient Age: 39 YR