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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 04/10/2014
Event Type  Injury  
Event Description

The patient underwent surgery at which time it was noted that there was no evidence that the generator had migrated. It was noted that the implanting surgeon inserted the generator through the axilla.

 
Manufacturer Narrative

 
Event Description

It was reported that the patient's generator is more towards his axilla than before and there has been some questioning if this is due to the patient's activity at the gym along with fighting with his brother. No surgical intervention has been performed to date.

 
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Brand NamePULSE GEN MODEL 102
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3809026
Report Number1644487-2014-01266
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/15/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/13/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2013
Device MODEL Number102
Device LOT Number3079
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received06/20/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/04/2011
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: 05/13/2014 Patient Sequence Number: 1
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