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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 09/01/2012
Event Type  Injury  
Event Description

Clinic notes dated (b)(6) 2012 were received on (b)(6) 2012. The patient presented for low battery. The patient had excellent prior response to stimulation with reduction of seizures and earlier abortion of her seizure episodes with use of the magnet. May weeks ago, the patient began having sporadic discharges from her vns which results in throat discomfort, coughing, breathing difficulties, and speech hoarseness. The patient was also concerned that the increase in seizures could make it difficult to work. The notes stated that the patient needed urgent replacement of her device due to the severe symptoms attributable to low battery resulting in sporadic discharges. An implant card dated (b)(6) 2012 indicated that the patient underwent generator revision on (b)(6) 2012 due to battery depletion.

 
Event Description

On (b)(6) 2012, it was reported that the device had been discarded. Attempts for additional information have been unsuccessful.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 103
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 Key2847361
Report Number1644487-2012-03116
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/31/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/27/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2011
Device MODEL Number103
Device LOT Number2427
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/11/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/03/2009
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: 11/27/2012 Patient Sequence Number: 1
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