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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
Event Date 07/01/2012
Event Type  Injury  
Event Description

A letter was received from the treating physician in response to the follow-up on (b)(6) 2013. In relation to the patient's pain, she provided the physician a history of pain developing approximately 6 months prior to january. She describes it as being located in the left chest, predominantly around and below the generator device with a lesser degree of discomfort within the neck region of the attachment to the vagal nerve and less so within the left temporal parietal region of the head. The patient initially had reported some transient discomfort on the right side, but that has dissipated and is now predominantly in the left side. The patient has had plans for evaluation for replacement of the generator based on the timeframe involved for the placement of the generator, but has also undergone chest x-ray and lead integrity x-rays, the results of which are still pending. However, she is undergoing plans for pre-operative evaluation for replacement. Per the physician, these plans of course were not done to preclude a serious injury, as he doubts that there would be unless her seizures increase tremendously, which they have thus not done. For patient comfort, he believes these plans were necessary. The outcome of many of these tests for the patient's symptomatology are pending. The physician does not believe that there were any programming or medication changes that preceded the onset of pain based his my records, and there was no known manipulation or trauma that occurred that both the patient and physician are aware of that would contribute to her pain. Although surgery is likely, it has not occurred to date.

 
Event Description

Analysis of the generator was completed. The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

 
Event Description

The patient had prophylactic generator replacement on (b)(6) 2013. The explanted device was received by the manufacturer on (b)(6) 2013, however product analysis has not been completed to date. The return product form confirmed the reason for replacement and showed eri=no.

 
Manufacturer Narrative

Age at time of event, corrected data: the initial report inadvertently reported the date of the event and therefore the patient's age at the time of the event incorrectly based on the additional information received from the physician. Date of event, corrected data: the initial report inadvertently reported the date of the event incorrectly based on the additional information received from the physician.

 
Manufacturer Narrative

 
Event Description

Clinic notes dated (b)(6) 2012 were received for the patient's prophylactic generator replacement, which indicated that the patient had no seizures since last seen in (b)(6) 2012. However, patient "has noted some intermittent little sharp stabbing pains sometimes associated with movement, not clearly associated with discharge of the unit, which is still going off, but she is 8 years out this month for placement and may need a replacement of her generator. " interrogation was performed on this date which confirmed the vns settings were unchanged from (b)(6) 2012, and device diagnostics showed no changes and were within normal limits. Device showed it was not at end of service. The patient was referred for surgical consult to assess whether she needed a prophylactic replacement generator and leads, as it was "that time. " the physician also noted that there are "possible adhesions in the vns generator pocket causing position related movement pain in the generator versus possible subclinical premature discharge of the unit because of end of service," as it has been implanted for eight years. Attempts for additional information from the treating physician have been unsuccessful to date. Although surgery is likely, it has not occurred to date.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
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 herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2921077
Report Number1644487-2013-00184
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/19/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/17/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2006
Device MODEL Number102
Device LOT Number011066
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/15/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/19/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/09/2004
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: 01/17/2013 Patient Sequence Number: 1
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