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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 07/11/2012
Event Type  Malfunction  
Event Description

A company representative in (b)(4) was contacted by a vns treating physician and it was reported that a patient's vns pulse generator could not be interrogated. The generator could not be turned off, as it could not be interrogated, so the magnet was secured onto the area of the patient's chest where the generator was. It was also reported through the company representative that the patient was experiencing apnea. Further information was received from a neurologist stating that vns was related to the patient's apnea and that the apnea episodes occurred with the generator pulses. The product information was unknown to the neurologist because the generator could not be interrogated. It was planned to remove the generator on (b)(6) 2012. Troubleshooting was performed by testing the programming wand's 9v battery, but a fresh 9v battery was not tested; different wands and handheld computers were tested and the interrogation of the reported generator was not successful. The generator was interrogated in different locations; the handheld computer was not connected to an outlet during interrogation; other patients' generators could be interrogated with the physician's programming system therefore, ruling out an issue with their programming system. No causal or contributory programming or medication changes preceded the onset of the apnea; the patient has no medical history of apnea before implanting vns. Good faith attempts are underway to see if the explanted generator can be returned for analysis.

 
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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 herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2682924
Report Number1644487-2012-01954
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/11/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number102
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date09/13/2012
Event Location Other
Date Manufacturer Received09/13/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 08/06/2012 Patient Sequence Number: 1
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