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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

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CYBERONICS - HOUSTON LEAD MODEL 302 Back to Search Results
Model Number 302-30
Device Problem Low impedance (2285)
Patient Problems Undesired Nerve Stimulation (1980); Numbness (2415); No Code Available (3191)
Event Date 11/01/2004
Event Type  malfunction  
Event Description
It was reported by a nurse in the patient's group home that the patient was complaining that he felt electricity through his body on and off throughout the day.The patient also reported that his left arm felt heavy and numb.Follow up with the patient's neurologist revealed that the neurologist was unaware of the events.During review of the manufacturer's programming history database, it was revealed that a dcdc code of 0 was present during system diagnostics.The dcdc code, while possibly within normal limits, and the reported events are possibly indicative of low impedance.No additional information has been received to date.
 
Event Description
It was reported that the patient's mother felt that the vns had never really helped the patient with his seizures and that she did not want the vns replaced.It is unknown whether the lack of efficacy was related to the possible low impedance.No additional relevant information has been received to date.
 
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Brand Name
LEAD MODEL 302
Type of Device
LEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key7529711
MDR Text Key108869502
Report Number1644487-2018-00820
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 06/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/31/2005
Device Model Number302-30
Device Lot Number8350
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 04/26/2018
Initial Date FDA Received05/21/2018
Supplement Dates Manufacturer Received05/30/2018
Supplement Dates FDA Received06/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/24/2003
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age26 YR
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