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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 12/01/2010
Event Type  Injury  
Event Description

Additional information was received indicating that given the patient's genetic condition, (b)(6), the patient could experience pulmonary events. If the patient were to cough a couple of times in succession, she could experience a pulmonary embolism. It is believed that the coughing the patient experienced with device stimulation did contribute to the patient having pneumothorax. The physician did not have any additional information to provide.

 
Event Description

It was reported on (b)(6) 2012 that an implanted patient was experiencing coughing associated with stimulation once the device was turned on, which resulted in the patient having a pneumothorax 4-5 times; however, the reporter also stated that the patient "had some additional pneumothorax events after the device was turned off, so they appear to not be related to stimulation. " the patient has a history of lymphangioleiomyomatosis (lam) and tuberous sclerosis. The patient expressed wanting the device explanted; therefore, surgery is likely but has not been scheduled to date. Good faith attempts to obtain additional information have been unsuccessful.

 
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Brand NamePULSE GEN MODEL 103
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 grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2488590
Report Number1644487-2012-00690
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/15/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/12/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2012
Device MODEL Number103
Device LOT Number201534
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/16/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/29/2010
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: 03/12/2012 Patient Sequence Number: 1
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