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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 03/19/2014
Event Type  Injury  
Event Description

It was reported that a seizure caused the dehiscence. The patient underwent another revision on (b)(6) 2014. The physician indicated that a resection of a neuroma in both the generator site and electrode site occurred. The patient later underwent explant of both the generator and lead. No additional relevant information has been received to date.

 
Event Description

It was reported that the vns patient underwent surgery on (b)(6) 2014 due to inflammation, dehiscence, and extrusion of the lead at the generator site. In (b)(6) 2014, the patient presented with drainage at the generator site. The surgeon stated that no infection had developed and attributed the event to vns implant surgery. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

 
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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 Key4012570
Report Number1644487-2014-02032
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/21/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/15/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2015
Device MODEL Number103
Device LOT Number3773
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/13/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/17/2013
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: 08/15/2014 Patient Sequence Number: 1
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