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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC.VNS THERAPY PULSEPULSE GENERATOR

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CYBERONICS, INC. VNS THERAPY PULSE PULSE GENERATOR   Back to Search Results
Model Number 102
Event Date 01/01/2004
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Patient's wound dehisced some time after suture removal following implant surgery. The patient was reportedly seen in hospital emergency room, at which time the wound was "sewn back up. " at recent office visit, treating neurologist indicated that he could not palpate the generator. Review of subsequent chest x-ray revealed that no generator was present in the chest along with no evidence of the lead. Investigation to date has been unable to determine the location of the devices or whether the patient removed the lead and/or generator through the incision sites. The patient's family member has reportedly searched their home for the lead and generator with no success. Repeat x-rays and follow up with neurosurgeon are planned. Investigation to date has been unable to determine the cause of the reported wound dehiscence.

 
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Brand NameVNS THERAPY PULSE
Type of DevicePULSE GENERATOR
Baseline Brand NameVNS THERAPY PULSE
Baseline Generic NamePULSE GENERATOR
Baseline Catalogue NumberNA
Baseline Model Number102
Baseline Device FamilyNA
Baseline Device PMA NumberP970003
Baseline Shelf Life Information Yes
Is Baseline 510(K) Number Provided? No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed06/20/2002
Manufacturer (Section F)
CYBERONICS, INC.
houston TX *
Manufacturer (Section D)
CYBERONICS, INC.
houston TX *
Manufacturer Contact
darlene garner, rac
100 cyberonics blvd.
ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key562878
MDR Report Key573008
Event Key544592
Report Number1644487-2005-00084
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 01/18/2005
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/15/2005
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number102
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/18/2005
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/15/2005 Patient Sequence Number: 1
#TreatmentTreatment Date
MODEL 302-30 VNS THERAPY LEAD
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