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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 Programming Issue
Event Date 12/02/2014
Event Type  Malfunction  
Event Description

Clinic notes were received indicating that the vns patient¿s device had been disabled in (b)(6) 2008 due to painful stimulation. It was reported that during an office visit on (b)(6) 2014, the physician was considering programming the device back on due to the patient¿s condition, but was unable to interrogate the patient¿s device despite using two known working programming systems. No known surgical interventions have occurred to date.

 
Event Description

It was reported that no further attempts have been made to interrogate the patient's device. Insurance coverage is being obtained for revision surgery. The patient experienced returns of suicidal thoughts which was reported to be related to the progression of the patient's depression. Suicidal ideations are not new for this patient and the return of the suicidal thoughts are unrelated to vns.

 
Manufacturer Narrative

 
Event Description

An implant card was received indicating that the device was still unable to interrogate at the replacement surgery. The reason for replacement was identified as "battery depletion, unable to interrogate due to battery depletion. " the explanted generator has been received by the manufacturer. Analysis is underway , but has not been completed to-date.

 
Event Description

Analysis was completed for the returned generator. The reported failure to program was determined to be the result of normal battery depletion. The depletion was an expected event as determined by battery life calculation and battery voltage measurement. The module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Manufacturer Narrative

Initial reporter: the incorrect contact information for the initial reporter was provided inadvertently. Relevant tests/laboratory data: the available device settings and estimate of battery life calculation were inadvertently not provided in the initial report.

 
Event Description

It was reported that the patient has had an increase in depression, and has made suicide attempts. Medication changes were considered. The patient had generator replacement surgery on (b)(6) 2015. The explanted product has not 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 Key4369050
Report Number1644487-2014-03474
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/02/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/30/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2007
Device MODEL Number102
Device LOT Number013118
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/20/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/09/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/16/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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