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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR Back to Search Results
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 12/01/2015
Event Type  Injury  
Event Description
It was reported by the physician's assistant that the patient was referred for prophylactic generator replacement due to painful stimulation the patient was experiencing.System diagnostics were unable to be performed due to the pain the patient would experience while running the diagnostics, so x-rays were taken.The x-rays were reviewed by company representative and based on the images the cause for the patient's painful stimulation could not be determined.There did not appear to be any gross fractures or discontinuities.However, the portion of the lead not visualized that would be in the chest could not be assessed; therefore, a lead fracture in that portion of the lead couldn't be ruled out.The presence of a micro-fracture could also not be ruled out.On the date of surgery, after the patient was put under, system diagnostics were run on two occasions with the patient's neck turned in different direction.The diagnostics showed the device was functioning as intended and no high impedance was detected.The surgeon decided to only replace the generator since there was no evidence that the leads had any issues.Surgery was completed on (b)(6) 2016.No additional relevant information has been received to date.
 
Event Description
Product analysis (pa) for the returned generator was completed.During analysis if was confirmed that the septum of the generator was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.In the lab, the device output signal was monitored for more than 24 hours, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the generator's output signal and demonstrated the device provided the expected level of output current for the entire monitoring period.The generator diagnostics were as expected for the programmed parameters.The generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the generator.
 
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Brand Name
PULSE GEN MODEL 102
Type of Device
GENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key5850759
MDR Text Key51275171
Report Number1644487-2016-01758
Device Sequence Number1
Product Code LYJ
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,health
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 07/07/2016
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 Date01/31/2009
Device Model Number102
Device Lot Number016932
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2016
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 07/07/2016
Initial Date FDA Received08/05/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2007
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 Age52 YR
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