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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Convulsion, Clonic (2222); Irritability (2421); Confusion/ Disorientation (2553)
Event Date 02/17/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the patient¿s mother to the physician that the patient had not been eating well and became ill after vns therefore it was requested that vns be turned off.The patient is now grabbing the device and scratching her chest a lot which is causing injury to the skin.During follow-up, the physician indicated that the cause for eating issues was not related to vns.The patient is autistic and is fixated on the generator site which is why they are itching.There is no injury to the skin and no swelling, just irritation from the patient touching it constantly.Clinic notes for the patient were received indicating that after vns was turned on initially, this would aggravate the patient more which had a tendency to worsen her seizures.The vns ended up being disabled after 3 months but was reattempted to be enabled for a week before it was turned off again.The patient has a tendency to obsess over the generator and pulls on it which irritates her skin.The patient currently does have magnet mode on for the longer prolonged seizures but this does not resolve the patient's concern regarding obsession of device and for this reason, the parents would like to have it removed.The patient had the device explanted but no product has been received to date.No additional relevant information has been received to date.
 
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Brand Name
PULSE GEN MODEL 106
Type of Device
GENERATOR
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
dana sprague
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key12099566
MDR Text Key259375487
Report Number1644487-2021-00894
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750061
UDI-Public05425025750061
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Physician
Type of Report Initial
Report Date 07/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date12/09/2017
Device Model Number106
Device Lot Number203667
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 06/15/2021
Initial Date FDA Received07/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/12/2016
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 Outcome(s) Required Intervention;
Patient Age9 YR
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