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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 101 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 101 GENERATOR Back to Search Results
Model Number 101
Event Date 08/08/2012
Event Type  Injury  
Event Description

Patient notes dated (b)(6) 2012, were received on (b)(6) 2012, regarding this vns patient. The notes indicated that patient was seen in consult for removal of the vns. The patient had the vns placed roughly 10-12 years ago for seizures (occurring since birth). The patient was now only on keppra for his seizures. The patient had not had a grand mal seizure in a long time, but continued to have frequent petite mal seizures. The patient said he had the vagal nerve stimulator on for about a year; however, it was then turned off because he was not benefiting from the vagal nerve stimulator. Since that time, it has been nonfunctioning in his body. The patient initially did not have any problems, but noticed a few years ago that he would get collections and hard swelling at the generator site that was occasionally painful, especially after working hard. This typically resolved over the course of a night. The swelling became more frequent over the last year and now happens every day or every other day. The patient requested the device be removed due to the discomfort. No neck problems related to the lead were experienced. The patient reported that he had not had any fever, chills, or signs of infection. The patient's programming history was reviewed, and it was noted that the patient's device was disabled on (b)(6) 2003. At this time, system diagnostic results indicated high impedance. A battery life calculation performed yielded negative results. Surgery is likely, but has not occurred. Attempts for additional information have been unsuccessful.

 
Manufacturer Narrative

Analysis of programming history.

 
Event Description

On (b)(6) 2012, it was reported that this vns patient underwent explant surgery on (b)(6) 2012. Attempts for product return were unsuccessful as the devices were reportedly discarded after explant. Attempts for additional information have been unsuccessful. The high impedance event is captured in mfr report #1644487-2012-02697.

 
Manufacturer Narrative

Relevant data with dates, corrected data: previously submitted mdr provided system diagnostic and programmed data for (b)(6) 2012; however, this date should be (b)(6) 2003. This report is being submitted to correct this data.

 
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Brand NamePULSE GEN MODEL 101
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 Key2764061
Report Number1644487-2012-02463
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/30/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/28/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2001
Device MODEL Number101
Device LOT Number29648C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/02/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/07/1999
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: 09/28/2012 Patient Sequence Number: 1
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