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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 03/18/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient's generator incision site had opened postoperatively and that the generator was visible. Patient went to ed and the physician closed the wound under sterile conditions with derma bond. Patient was discharged from the ed with 2 weeks worth of antibiotics. Patient did not report any discomfort but was able to see the generator. Patient was occasionally able to see yellow discharge from the wound. Patient is overall tolerating the stimulation well. No fevers or other signs of infection were present. The chest would was 90% healed with small dehiscence in the center of the wound, exposing the generator. Mild erythema to the wound edge was also present. Vns was interrogated and programmed to 2. 0mamp with no lead impedance noted. Due to infection, the patient later underwent generator was explanted on (b)(6) 2016. The explanted generator has not been received to date. A review of device history records showed that both the lead and generator were sterilized prior to distribution.

 
Event Description

Per clinic notes received, both neck and chest incision nicely healed with no sign of 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 Key5621104
Report Number1644487-2016-00922
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup
Report Date 04/06/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/29/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2017
Device MODEL Number106
Device LOT Number203657
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/27/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/07/2016
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: 04/29/2016 Patient Sequence Number: 1
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