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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/29/2008
Event Type  Injury  
Manufacturer Narrative

Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device.

 
Event Description

It was reported that the patient's device had been explanted several years ago due to an infection. Further follow-up found that the infection first presented following the initial implant of the device and the patient was treated with antibiotics. A dehiscence wound developed at the lower part of the incision due to a retained suture. Then several years later a blister developed at the same site which eventually began to dehisce and drain. This lead to an infected generator pocket. The generator and partial lead were then explanted due to this infection. A review of manufacturing records showed that both the lead and generator were sterilized prior to distribution.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7233112
Report Number1644487-2018-00127
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/31/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/31/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2010
Device MODEL Number102
Device LOT Number200816
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/05/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/04/2008
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: 01/31/2018 Patient Sequence Number: 1
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