MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Cellulitis (1768); Erythema (1840); Unspecified Infection (1930); Swelling (2091); Shock from Patient Lead(s) (3162)

Event Date 08/25/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported on that this patient was recently implanted on (b)(6) 2015 and the device was activated on (b)(6) 2015.The patient's mother called in stating that the patient is complaining of shocking sensations at the site of the generator.When the patient's device was activated, the patient tolerated that well.It was then noted from a nurse at the surgeon's office that she as a 4 inch line from the generator up to her neck that is red, swollen and hot.The patient states it keeps shocking her.There was no breakdown of the incision and the incision was said to look nice.It was noted that the patient was being admitted.The patient had a 3rd dosing and she tolerated well.The patient was diagnosed with cellulitis and it is now resolved with medication and iv.The infection was attributed to the implant procedure.The patient is now doing well.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5131124
• MDR Text Key: 27672315
• Report Number: 1644487-2015-06036
• 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
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/16/2017
• Device Model Number: 106
• Device Lot Number: 4349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2015
• 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: 9 YR