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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 10/01/2011
Event Type  Injury  
Event Description

It was initially reported that a vns patient implanted in (b)(6) 2011 had to have the lead and generator removed due to pocket erosion. The surgeon indicated it looked as though someone had cut the stitches and the wound opened up; therefore, the lead and generator were removed on (b)(6) 2011. Additional information received revealed that there was no infection. The patient was able to see the vicryl suture at the edge of the generator (used to secure the generator to the fascia) and the patient cut the suture off which is believed to have resulted in the surgical wound opening up and separating. There was no frank evidence of infection when the incisions were opened and the lead and generator were removed. The neck incision was then closed once the lead was removed. The generator site was packed with triple-antibiotic soaked nu gauge. The patient did was admitted on (b)(6) 2011 and discharged on (b)(6) 2011. No further information has been provided at this time.

 
Event Description

The patient's implant information was received and has been included in this report.

 
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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
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2297702
Report Number1644487-2011-02475
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/04/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/17/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2012
Device MODEL Number103
Device LOT Number3049
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/17/2011
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/13/2011
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: 10/17/2011 Patient Sequence Number: 1
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