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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Event Date 12/28/2014
Event Type  Injury  
Event Description

It was reported that the patient experienced wound dehiscence following generator replacement on (b)(6) 2014. The surgeon saw the patient on (b)(6) 2014 and there were no signs of infection. Prophylactic antibiotics were given. The wound was reported to be 90% healed on (b)(6) 2015. No additional relevant information has been received to date.

 
Manufacturer Narrative

Udi: (b)(4).

 
Manufacturer Narrative

Date received by manufacturer (mo/day/yr), corrected data: follow-up report #1 inadvertently did not list the received date of (b)(4) 2015.

 
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Brand NamePULSE GEN MODEL 104
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 Key4532251
Report Number1644487-2015-03922
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/23/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/20/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2016
Device MODEL Number104
Device LOT Number4153
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/14/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/25/2014
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: 02/20/2015 Patient Sequence Number: 1
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