MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Tissue Breakdown (2681); Fluid Discharge (2686)

Event Date 10/26/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluation not needed because the reported events have been determined as not related to vns therapy and stimulation.(b)(4).

Event Description

Report received that a patient's generator was exposed in the left chest.The patient was reportedly admitted to the hospital and put on antibiotics before the generator was to be explanted.Further information was received that the patient's neurologist believed an infection caused the generator to extrude from the skin, but the origin of the infection was reportedly unknown.Further information was received from operative notes that about a month prior to the extrusion, the patient presented with multiple erythematous areas over her neck and chest.It was noted that the patient's neurologist evaluated these bumps and determined they were related to insect bites.However, it appeared the patient did not recover with antibiotics and the generator began to extrude from the wound.It was not stated whether these insect bites led to the infection.The patient's mother reported that the site opened up and a gush of red tinged drainage was seen.The op-notes stated that during the explant, the generator was removed and the wound was cleaned.They also indicated that the surgeon removed some scar tissue in the generator area while performing the surgery.A review of the device history record indicated the generator had been properly sterilized to specifications prior to release for distribution.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 105
• 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: 7047271
• MDR Text Key: 92584381
• Report Number: 1644487-2017-04840
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750054
• UDI-Public: 05425025750054
• 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: Physician
• Type of Report: Initial
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/29/2017
• Device Model Number: 105
• Device Lot Number: 203778
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/03/2016
• 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: 52 YR