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

Model Number 106

Device Problems Failure to Interrogate (1332); Migration or Expulsion of Device (1395)

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

Event Date 11/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported on (b)(6) 2016 from clinic notes dated (b)(6) 2016 that the patient is scheduled to have her device moved to her upper left chest due to migration.It was stated that the physician had tried to interrogate the device (b)(6) 2016.However this was unable to be completed because the device has now sunken to her lower breast tissue and since he has a lot of breast tissue it is no longer able to be interrogated.Therefore the device needs to be moved to her upper chest area.It was reported that a non-absorbable suture was not used to secure the generator to the tissue.The cause of the migration is unknown.No further relevant information has been received to date.

Event Description

The surgery to move the device was re-scheduled.No known surgery has occurred to-date.

Event Description

Repositioning surgery was performed on (b)(6) 2017 to allow easier interrogation of the generator.The generator was confirmed to be able to interrogate in the relocated position.The surgeon sutured it in place, using a suture with greater tensile strength.

• 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: 6155993
• MDR Text Key: 61814734
• Report Number: 1644487-2016-02816
• 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,Followup
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/04/2018
• Device Model Number: 106
• Device Lot Number: 203684
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2016
• 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: 50 YR