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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 08/07/2011
Event Type  Injury  
Event Description

It was reported by a company rep that a vns pt experienced an increase in seizures after initially responding well to vns therapy. The pt's programmed settings were 1. 75 ma and system diagnostics were within normal limits (ok/ok/2/no). Add'l info was received from the area rep indicating that the pt began having a worsening in seizures in the beginning of (b)(6). The treating physician indicated that the pt's increase is of unk cause and possible causes could be battery depletion and/or pt's worsening condition. Interventions taken were to reprogram the pt to other device settings in hopes to re-establish seizure control. A pre-vns baseline for seizures was unk and future plans are to replace the pt's generator since end of service might be near.

 
Event Description

Attempts to obtain the explanted device have been unsuccessful to date as the physician does not recall the replacement surgery.

 
Event Description

Further information was received through an implant card indicating the patient underwent prophylactic generator replacement surgery. Good faith attempts to obtain the explanted device returned for analysis remains underway.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2251406
Report Number1644487-2011-02150
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 08/15/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/13/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date01/31/2009
Device MODEL Number102
Device LOT Number016869
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/02/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2007
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: 09/13/2011 Patient Sequence Number: 1
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