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

Model Number 106

Device Problem Device Handling Problem (3265)

Patient Problem Wound Dehiscence (1154)

Event Date 06/26/2016

Event Type  Injury  

Event Description

It was reported that vns patient underwent a generator replacement.The reason mentioned on the implant card was "patient cut the incision".The lead impedance was ok after the replacement.The explanted generator was implanted on (b)(6) 2016.Further follow up indicated that the patient (mentally delayed) was implanted with the vns therapy since 2010 with positive outcome.He was admitted to the general hospital in the remote region on (b)(6) 2016, where they looked over the incision, they cleaned the wound, and stick dressing on the wound.While visiting the vns clinic as regular procedure to ramp up the device on (b)(6) 2016, they looked over the incision and found out the wound was open (patient was trying to remove out the device).The patient was admitted directly to the or for the next day on (b)(6) 2016 to clean and seal the wound.The neurosurgeon decided to replace the generator prophylactically; he cleaned the wound and changed the position of the generator in order not to have any infection.No explanted device is available to be returned to the manufacturer for analysis.The review of the manufacturing records confirmed the sterilization with (hp method) for the generator prior to the distribution.

Event Description

The review of the manufacturing records confirmed the sterilization with (hp method) for the lead prior to the distribution.Further follow up indicated that the lead was not replaced.

• 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: 5942292
• MDR Text Key: 54401500
• Report Number: 1644487-2016-02027
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/10/2016
• Device Model Number: 106
• Device Lot Number: 203083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2014
• 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: 27 YR