MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994)

Event Date 06/04/2016

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported that patient has delayed post op infection, not oozing any further; patient was given antibiotics.It was reported that vns was turned on 0.25ma, patient did tolerate the therapy.Additional information was received that patient was implanted on (b)(6) 2016.Initially both electrode and generator sites were sore and after around two weeks on implant, the wound on generator site was oozing.Additional information was received that the wound has healed now.

Manufacturer Narrative

(b)(4).

Event Description

Further information was received on (b)(6) 2016 that the neurologist is referring the patient back to the surgeon for further assessment of the wounds, they remain very sore/painful, and do look quite raised.Review of manufacturing records confirmed sterilization with hp for the lead and the generator prior to distribution.

• Brand Name: PULSE GEN MODEL 105
• 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: 5905945
• MDR Text Key: 53073717
• Report Number: 1644487-2016-01923
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2017
• Device Model Number: 105
• Device Lot Number: 203352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2015
• 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: 26 YR