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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 08/14/2012
Event Type  Injury  
Event Description

It was reported by a surgeon that the patient was being scheduled for explant. The surgeon indicated that the device had never really helped with her depression and the patient had been experiencing problems with hoarseness during stimulation and shortness of breath so the patient was being explanted. Attempts for additional information have been unsuccessful to date.

 
Event Description

Additional information was received on (b)(6) 2012 when the physician reported that it is unknown when the lack of efficacy, hoarseness, and shortness of breath first began. He also stated that it is unknown what the cause of the lack of efficacy is. It was also unknown what the relationship between hoarseness and the shortness of breath to vns was as well as whether or not they were occurring with stimulation. The physician stated that no interventions have been taken and it was unknown if causal or contributory programming or medication changes preceded the onset of the shortness of breath. The patient does not have a medical history of shortness of breath pre-vns. A battery life calculation was performed on (b)(6) 2012, which showed 5. 16 years remaining until neos=yes.

 
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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2743583
Report Number1644487-2012-02306
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/14/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/13/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/30/2007
Device MODEL Number102
Device LOT Number013177
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/18/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/22/2005
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: 09/13/2012 Patient Sequence Number: 1
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