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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 06/28/2013
Event Type  Injury  
Event Description

It was reported that the vns patient was experiencing painful stimulation in his neck. The patient¿s device settings were lowered but the patient subsequently experienced an increase in seizures. The patient¿s device settings were programmed back to previous settings and the patient¿s painful stimulation returned. X-rays dated (b)(6) 2013 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the reported event remains unknown. Follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2013. The replacement generator was tested with the existing lead and diagnostics showed lead impedance within normal limits (impedance value ¿ 1650 ohms). The patient continued to experience painful stimulation following surgery. The explanted generator has not been returned to date.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

 
Event Description

On (b)(6) 2014, it was reported that this patient¿s explanted generator was discarded at the time of explant. Attempts for additional information have been unsuccessful.

 
Manufacturer Narrative

Previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data.

 
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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 Key4245608
Report Number1644487-2014-03002
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/26/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/12/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2015
Device MODEL Number102
Device LOT Number202460
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/11/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/19/2013
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: 11/12/2014 Patient Sequence Number: 1
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