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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 100

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CYBERONICS, INC. PULSE GEN MODEL 100 Back to Search Results
Model Number 100
Event Date 08/01/2010
Event Type  Injury  
Event Description

It was reported that the vns patient had the vns generator explanted as the device was protruding and the skin was beginning to erode. F/u with the surgeon's office revealed that they opted to explant the device to prevent any further worsening of the skin erosion so as to prevent a possible infection at the wound site. The pt's device had been programmed off for some time, as it was noted by the patient's treating neurologist that vns therapy was not providing the patient with much benefit for seizure control. There was no report of any causal or contributory pt manipulation to the device site. The exact cause of the protrusion of the pulse generator was not able to be ascertained when following up with the surgeon's office. Good faith attempts to obtain the explanted device for analysis are underway.

 
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Brand NamePULSE GEN MODEL 100
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste 600
houston , TX 77058
2812287200
MDR Report Key1845929
Report Number1644487-2010-02120
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 08/18/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/17/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2000
Device MODEL Number100
Device LOT Number17789C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/18/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/1998
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: 09/17/2010 Patient Sequence Number: 1
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