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Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/21/2017
Event Type  Injury  
Manufacturer Narrative

Device evaluation was not necessary because the reported event has been determined as not related to vns therapy.

Event Description

It was reported that the patient was to have her vns generator and the generator pocket washed out with the leads remaining implanted. The company representative reported that at the initial post-op follow up appointment for the implantation surgery, the patient appeared to exhibit flu-like symptoms and the surgeon thought it was not an infection at the time. It was reported that standard protocol post-surgery antibiotics were given following the surgery. The patient reported getting infections in the past from past surgeries, which were not vns surgeries. The patient underwent vns generator explant surgery. The patient later provided a detailed timeline of the events. At the post-op follow up, there was redness at the neck incision. The following day, the patient awoke to pain and a lump on the neck. The pain increased over the day and the incision opened with a purulent discharge. The patient went to the er and received iv antibiotics. The surgeon saw the patient at the hospital the next day and the patient was discharged with oral antibiotics. On the next follow up, the patient felt that the neck incision appeared better. However, the generator incision was red and appeared to have an infection. Cultures indicated both aerobic and anaerobic bacteria. The patient stated that she always had a propensity to infections following surgery. A review of device history records showed that both the lead and generator were sterilized prior to distribution. No additional relevant information has been received to date.

Event Description

It was reported by the surgeon's office that the patient presented to the surgeon's office and the incision site was still draining. It was stated that the surgeon used a stitch or two and changed the patient's antibiotic. The patient later contacted the manufacturer and provided more details. The patient had her stitches removed previously at a follow-up appointment with the surgeon. The surgeon had placed steristrips on the wound. Later that day, the steristrips and bandage came off, leaving the patient with an open wound. The patient had presented to the surgeon's office the next day, where he re-stitched the patient and placed her on the aforementioned antibiotics. Clinic notes were later received indicating that the patient reported scant drainage and no pain. The patient was getting along well tolerating the current antibiotics. The wound was sealed and there was no active drainage or erythema. It was stated that the patient was improving despite the fact that there was a little bit of abnormality on the most recent culture.

Event Description

It was reported that the patient underwent vns re-implantation surgery. No further reports will be made unless new, relevant information to the infection is received.

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Type of DeviceGENERATOR
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key7198988
Report Number1644487-2018-00104
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 03/15/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/17/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number106
Device LOT Number204151
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/08/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/19/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial