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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
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/23/2016
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the patient underwent explant of vns. Notes from explant surgery were received indicating that the reason for the explant was due to infection and cellulitis in the neck and chest. Patient presented with complete dehiscence of the neck wound in the early postop period and underwent closure of the wound (previously reported in mfr. Report # 1644487-2016-00905). Since then, patient has developed symptoms of recurrent infection in her neck and chest wounds and this has been refractory to antibiotics. Infectious disease service was consulted and they recommended device explantation and iv antibiotics. During the surgery, the surgeon observed dense scar tissue. As he removed this tissue in the carotid sheath, there was profuse bleeding from the side wall of the internal jugular vein that result in rapid blood loss. The surgeon was able to control this and then repaired the defect in the wall. The electrode was cut after it was removed from around the vagus nerve. The neck wound had dense scar tissue but no fluid or granulation tissue. In the chest, the pulse generator was removed with the cut half of the electrode still attached. The surgeon then removed extensive granulation tissue from the chest wound subcutaneous tissues and muscle. The surgeon obtained fluid from the chest wound and this was sent for culture and sensitivity. The chest wound was debrided and granulation tissue was sent for pathological examination. The neck and chest wounds were copiously irrigated with bacitracin irrigation and the wounds were then closed. A review of device history records showed that both the lead and generator were sterilized prior to distribution. Products were received for analysis but not completed to date.

 
Manufacturer Narrative

(b)(4).

 
Event Description

A large portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the lab, there is no evidence to suggest an anomaly with the returned portion of the device. The pulse generator diagnostics were as expected for the programmed parameters. The pulse generator performed according to functional specifications of final configuration r-wave test. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse condition found with the pulse generator.

 
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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 Key6330818
Report Number1644487-2017-03206
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/13/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/14/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/27/2018
Device MODEL Number106
Device LOT Number203703
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/06/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/27/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/17/2016
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: 02/14/2017 Patient Sequence Number: 1
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