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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 102R GENERATOR

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CYBERONICS INC PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Event Date 02/01/2014
Event Type  Injury  
Event Description

It was reported that the vns patient was experiencing hoarseness, shortness of breath, and throat pain. The patient¿s asthma had exacerbated at the time. The patient was given steroids and an inhaler and the symptoms resolved. The patient later reported experiencing pain at the lead site and pain from laughing and coughing. The patient also reported discomfort at night and began snoring. The patient and patient's mother reported hearing and engine-like sound coming from the patient's device at night. The patient refused to have her device settings adjusted but noted that she was not using her magnet due to discomfort. Further follow-up revealed that x-rays were later taken and confirmed proper placement of the generator and lead; however, they showed chest wall infection with consolidation of the left lower lobe that was affecting her breathing. The patient is expected to receive antibiotics and a follow-up x-ray. Attempts for additional relevant information were made but have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 102R
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3800594
Report Number1644487-2014-01217
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/14/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/08/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number102R
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/14/2014
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: 05/08/2014 Patient Sequence Number: 1
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