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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
Event Date 07/07/2014
Event Type  Injury  
Event Description

Additional information was received stating that the patient experienced painful stimulation at the generator site. The generator replacement surgery was reported to be planned for patient's comfort and not to preclude a serious injury. There were no known vns setting changes or trauma to the site that could have caused or contributed to the painful stimulation. No known surgical interventions have occurred to date.

 
Event Description

An implant card was received indicating that the patient underwent generator replacement on (b)(6) 2014. Attempts made for the return of the explanted product were unsuccessful. The explanted product could not be located by the explant facility. Analysis of the product could not be performed as the product has not been received to date.

 
Event Description

A surgery referral form was received indicating that the patient was referred for generator replacement because of pain with vns stimulation for 2-3 months. It was noted that the generator is likely nearing end of service. Clinic notes dated (b)(6) 2014 indicate that the patient experiences more auras and will be referred for generator replacement because the generator battery is low. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful 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 770
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 Key4224345
Report Number1644487-2014-02920
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/07/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/04/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2006
Device MODEL Number102
Device LOT Number011863
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/30/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2005
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: 11/04/2014 Patient Sequence Number: 1
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