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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 12/01/2009
Event Type  Injury  
Event Description

It was initially reported by the physician, the patient was seen in the office due to severe neck pain which is located slightly lower than neck incision. Pain is associated with stimulation and started after she was wrestling with her children, and they were pretending to choke her around her neck. Physician wants to replace the whole system since he feels the battery needs to be changed anyway. Patient also had coughing and choking sensation with magnet stimulation. Device is currently been turned off due coughing and laryngospasm. Good faith attempts to obtain additional information has been unsuccessful.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS INC
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste 600
houston , TX 77058
2812287200
MDR Report Key1581537
Report Number1644487-2010-00079
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/14/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/13/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2005
Device MODEL Number102
Device LOT Number009273
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/14/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2003
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: 01/13/2010 Patient Sequence Number: 1
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