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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 06/26/2008
Event Type  Injury  
Event Description

A patient reported that his vns device had been removed prior due to painful stimulation and voice alteration. The patient's explant had previously been reported and was due to unknown reasons. The generator was returned for product analysis and verified that the generator performed according to all functional specifications and was able to adequately provide the intended therapy while placed in a simulated body environment. A review of the manufacturing records and diagnostic history also indicated proper device functionality. Follow-up was performed with the explanting facility, but no further relevant information was able to be received. 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 - 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 Key6394773
Report Number1644487-2017-03359
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT
Type of Report Initial
Report Date 03/10/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/10/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2008
Device MODEL Number102
Device LOT Number014007
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/01/2008
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/15/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/11/2005
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: 03/10/2017 Patient Sequence Number: 1
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