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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 02/24/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported on (b)(6) 2016 that the patient has swelling at the chest incision. The patient was implanted on (b)(6) 2016. The swelling was described as raised and warm to touch. The vns device is not on. There is no neck swelling. Of note, the patient does cpt (chest percussion therapy) vest therapy. He did cpt the 1st day postop and there was some bleeding of the chest incision site, so since then the cpt therapy has been discontinued. Follow-up with the surgeon's office showed that the patient was seen on the 10th. It was determined that the patient had a seroma above the chest incision and antibiotics were prescribed as a precaution for any infection that may develop and the seroma was drained at the appointment. No infection was confirmed but the precautionary medicines were provided. The patient's home was instructed to give the antibiotics. No explant of the device is planned. On (b)(6) 2016, it was reported that the patient's lead wire is poking through the incision.

 
Event Description

Clinic notes received (b)(4) 2016 and dated (b)(6) 2016 states that patient has problems with lead. It was stated it was complicated by a small seroma which was evacuated 2 weeks ago. The patient returns today with a small portion of the vns lead extruding through the skin. This is in the area where the seroma had thinned out the wound. There is no sign of infection or drainage. The surgeon recommends revising the pocket in such a way that his leads will be placed back in the tissue deeper. Due to the patient's mental status, this will have to be done in the or. The patient's surgical intervention has not occurred to date due to the patient being hospitalized for pneumonia and dehydration.

 
Event Description

It was reported on (b)(6) 2016 that the patient was taken to the hospital due to a hemotoma. The surgeon performed surgery that day to clean out the generator site due to the lead being exposed. System diagnostics performed at this surgery showed the device was working within specifications. It was reported on (b)(6) 2016 that the patient underwent a surgery that morning. It was stated that the patient had a hemotoma at the chest incision and the lead wire was still poking through the skin. The surgeon cleaned out the hematoma, covered the area in antibiotic powder and put a wound vac in place that he planned to keep in through the weekend. Per the nurse, the patient thrashed around a lot, picked at his incision site and they felt that was contributing to the problems.

 
Event Description

It was reported on (b)(6) 2016 that the patient is referred for explant as it appears that his body is rejecting the lead/generator. The patient now has an open incision. No confirmation of the explant surgery has occurred to date.

 
Event Description

The generator and the lead were explanted on (b)(6) 2016.

 
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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 Key5529930
Report Number1644487-2016-00654
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/09/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/28/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/29/2017
Device MODEL Number106
Device LOT Number4550
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/22/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/07/2015
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: 03/28/2016 Patient Sequence Number: 1
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