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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 08/17/2011
Event Type  Injury  
Manufacturer Narrative

 
Event Description

Reporter indicated the patient's vns was disabled on (b)(6) 2011 to evaluate for seizures. Replacement of the vns generator is not currently planned. The reporter does not know what to attribute the pain to. The pain was also occurring in the left upper extremity and jaw as well as the generator site. The patient's pain did improve somewhat with lowering the vns settings, but the response varies by appointment date.

 
Event Description

On (b)(6), 2011, a vns implanting surgeon's nurse reported that the vns pt was having their generator replaced due to increased seizures. The pt's programming history was reviewed and based on the pt's last setting of output=2. 75ma/frequency=25hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=3ma/magnet pulse width=250usec/magnet on time=60sec, the battery longevity tables revealed that the battery should last approximately around 2. 8 yrs from date of implant until eos. Although surgery is likely, it has not yet occurred. Good faith attempts for additional info from the physician regarding the pt's increased seizures have been unsuccessful thus far. When additional info is received, it will be reported.

 
Event Description

Reporter indicated a patient was experiencing severe pain at the vns generator site in the chest that was not related to stimulation. The patient did not want to stop vns stimulation. A referral to a surgeon was made, but no surgery date has been set as the surgeon ordered ct scans of the neck and neck. Surgery appears possible. A battery life analysis performed by the manufacturer yielded 4. 79 years remaining; generator end of service is not suspected. Attempts for further information are in progress.

 
Event Description

Reporter indicated the patient had vns generator repositioning surgery performed on (b)(6) 2012. Since the vns generator was repositioned, the patient's pain has decreased significantly. The patient has been released from surgery back to the care of his neurologist.

 
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Brand NamePULSE GEN MODEL 102
Type of DevicePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2246510
Report Number1644487-2011-02146
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup,Followup,Followup
Report Date 08/18/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/13/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date04/30/2011
Device MODEL Number102
Device LOT Number201152
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/29/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/14/2009
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: 09/13/2011 Patient Sequence Number: 1
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