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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 04/01/2008
Event Type  Malfunction  
Event Description

It was reported that the vns pt was seen by the physician due to pain in the neck. The physician only changed the on and off time which altered the duty cycle from 25% to 23%. Diagnostics were performed at the office and revealed normal device function. The next time the pt was seen by the physician was approx one half months later, and the pt had experienced an increase in seizure activity, relationship to pre-vns baseline unk. The neck pain had not resolved. There was no intervention taken to help with the seizures or the pain at this office visit. Diagnostics were performed and revealed normal device function. X-rays were taken and sent to mfr for review. There were no obvious anomalies observed on the x-rays that could be contributing to the events. The physician has referred the pt to a surgeon for a consult. Attempts to obtain additional info have been made, but have been unsuccessful to date.

 
Manufacturer Narrative

Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no obvious anomalies visualized.

 
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Brand NamePULSE GEN MODEL 102R
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
michael carroll
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1069997
Report Number1644487-2008-01517
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/22/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/02/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2005
Device MODEL Number102R
Device LOT Number009063
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/22/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2003
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: 07/02/2008 Patient Sequence Number: 1
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