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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 01/01/2014
Event Type  Injury  
Event Description

It was reported that the patient¿s generator was explanted on (b)(6) 2014. The explanted generator was received for analysis. Analysis of the generator was completed on (b)(6) 2014. Analysis showed that the pulse generator performed as expected and no adverse conditions were found with the device. Further follow-up revealed that the device was explanted due to multiple episodes of wound dehiscence. Attempts to obtain additional relevant information have been unsuccessful to date.

 
Event Description

It was reported that the patient would not leave the site alone, so the wound would not heal properly. The physician stated that there was no relationship to the wound dehiscence and vns.

 
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Brand NamePULSE GEN MODEL 103
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 Key4440927
Report Number1644487-2015-03677
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/30/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/22/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2014
Device MODEL Number103
Device LOT Number3326
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/14/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/28/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/13/2012
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: 01/22/2015 Patient Sequence Number: 1
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