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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 01/01/2011
Event Type  Injury  
Event Description

On (b)(6) 2013 it was reported that the patient needed assistance finding out how to get a new generator because her generator had "migrated" to "the edge of her left underarm". Per the patient, she had been seen by a surgeon and he recommended a new generator. Follow up with the physician found that the generator migration was first observed two years ago. The physician believes the generator has migrated and states that it is in axilla eight inches from where implanted. No patient manipulation or trauma occurred which is believed to have caused or contributed to the migration. Surgical intervention has been planned, but not taken due to insurance issues. The physician states that it would be optimal to replace or remove the vns device. No additional information has been provided.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3443526
Report Number1644487-2013-03369
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/03/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/01/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number102
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/03/2013
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: 11/01/2013 Patient Sequence Number: 1
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