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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Event Date 04/12/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that a patient that was recently implanted with vns was hospitalized due to an infection that required removal of the vns system. Clinic and operative notes were received on 04/21/2016 regarding the patient's infection. The patient had vns implant surgery on (b)(6) 2016 and was admitted to the hospital on (b)(6) 2016 due to nausea, chills, pain at the neck and chest incisions, odynophagia, and pain while moving her neck. The patient started having drainage at the neck area. After the patient was admitted to the hospital, it was determined that the patient had fever, tachycardia, and leukocytosis. There was evidence of inflammatory changes/edema in soft tissue of the left check and neck. The patient was diagnosed with sepsis secondary to left chest wall cellulitis. The patient's vns system was explanted on (b)(6) 2016 due to the infection. The patient was treated with antibiotics for a streptococcus pyogenes (group a). The patient was admitted to the hospital for surgery on (b)(6) 2016 due to "issues" with her incision. The patient was experiencing wound dehiscence at her neck incision after her vns system was explanted. Irrigation and debridement of the cervical wound and a revision of the wound was performed. It was not known if the wound dehiscence was a continuation of the previous infection, but it was stated that it could have been due to possible poor wound healing. The device history records of the lead and generator were reviewed, and both were sterilized according to procedure prior to release.

 
Event Description

Ct scans performed during the patient's visit on (b)(6) 2016 were provided on (b)(6) 2016. The indication for the ct scan was recent removal of implant for seizures with draining incision in the neck. The ct of the chest identified focal induration within the left breast which was nonspecific. There was no pathologically enlarged adenopathy or mass. In the neck. There was no evidence of discrete fluid collection or mass. The ct of the neck identified a small air-filled cavity in the anterior aspect of the neck along the medial aspect of the left sternocleidomastoid muscle. There was no discrete fluid collection to suggest abscess. The patient also had a picc line placed from the right arm for the infection.

 
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Brand NamePULSE GEN MODEL 106
Type of DeviceGENERATOR
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 Key5655090
Report Number1644487-2016-01017
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Followup
Report Date 04/19/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/13/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/03/2018
Device MODEL Number106
Device LOT Number4775
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/11/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/22/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/13/2016 Patient Sequence Number: 1
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