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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102R Back to Search Results
Model Number 102R
Event Date 03/23/2011
Event Type  Injury  
Event Description

It was reported via clinic notes received that the patient's seizures have "gotten worse and more frequent" in a note dated (b)(6) 2011 and "having more generalized seizures" in a note dated (b)(6) 2011. It was noted that the vns battery was low; however, it is unknown if this is the cause of the patient's seizures. The patient has been needing more rectal valium as a result and the patient's dilantin has been increased. Additional information was requested from the site; however, additional information relevant to the investigation was not provided. A rough battery life calculation was performed that estimated the generator was likely at, near, or past, end of service. Surgery to replace the patient's generator has occurred and the explanted product has been returned. The generator is currently undergoing analysis.

 
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Brand NamePULSE GEN MODEL 102R
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key2275352
Report Number1644487-2011-02301
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 08/29/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/28/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date07/31/2006
Device MODEL Number102R
Device LOT Number011252
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer09/21/2011
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/29/2011
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/01/2004
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: 09/28/2011 Patient Sequence Number: 1
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