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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 12/07/2009
Event Type  Injury  
Event Description

On november 7, 2011 clinic notes were received through case management. Review of the clinic notes dated (b)(6) 2009 revealed that the patient had her pacemaker interrogated that year and that the patient has obstructive sleep apnea. No relationship between the patient's arrhythmia and the obstructive sleep apnea to vns was provided in the clinic notes. Good faith attempts for additional information from the physician have been made but no further information was received.

 
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Brand NamePULSE GEN MODEL 102
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
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2350933
Report Number1644487-2011-02866
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 11/07/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/29/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date09/30/2006
Device MODEL Number102
Device LOT Number011454
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/07/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/10/2004
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: 11/29/2011 Patient Sequence Number: 1
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