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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2006
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient's vns was explanted two weeks after implant surgery due to infection. It is unclear if the lead and/or the generator was explanted. The manufacturer's device history records of the generator and lead were reviewed and sterilization was confirmed. No further relevant information has been received to date.

 
Event Description

Operative notes were received that described the patient's explant and wound debridement due to infection. The operating notes indicated that the patient had an eschar over the generator site that opened, revealing the generator itself. For this reason, the site was believed to be infected. The patient was not considered to be septic, toxic, or febrile on exam. It was indicated that the infection was localized to the subcutaneous tissue. The patient's full lead (including electrodes) and generator were explanted. The patient's eschar was removed. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 102
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 Key6350406
Report Number1644487-2017-03242
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 04/04/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/22/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2007
Device MODEL Number102
Device LOT Number013476
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/04/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/22/2005
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: 02/22/2017 Patient Sequence Number: 1
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