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MAUDE Adverse Event Report

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CYBERONICS, INC. VNS THERAPY LEAD BIPOLAR LEAD   Back to Search Results
Model Number 302-20
Event Date 06/04/2003
Event Type  Injury   Patient Outcome  Hospitalization; Required Intervention
Manufacturer Narrative

Report is incomplete because attempts to obtain additional info have been unsuccessful to date. No response has been rec'd to mfr's requests for additional info from treating neurosurgeon. Product analysis results will not change the conclusion of the reported infection because explanted products are decontaminated prior to return; therefore, microbiological testing is not performed. In the event that the device is explanted and returned, product analysis results will only be reported if a device malfunction is noted that would be likely to cause a death or serious injury if the malfunction were to recur. H. 6. Device mfg records were reviewed. Vns therapy labeling lists infection as a potential adverse event possibly associated with surgery. Review of mfg records for both the pulse generator and the bipolar lead confirmed sterilization of devices. The pt reportedly picked at the incision site and pulled a portion of the lead out through the incision.

 
Event Description

Reporter indicated that a portion of pt's lead was protruding from the incision site. Revision surgery was performed during which the exposed portion of the lead was placed back into the pocket. There were no signs of infection. Further follow-up revealed that the pt had picked at the incision site, and had pulled a part of the lead out through the incision. Following the revision surgery, the pt had again picked at the incision site and had again pulled a portion of the lead out through the incision. It was then reported that the pt had a staph infection at the generator site. The pt was seen by a different surgeon who covered the site with tegaderm and treated with bactroban ointment until the pt could be seen by their regular surgeon who was out of town at the time.

 
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Brand NameVNS THERAPY LEAD
Type of DeviceBIPOLAR LEAD
Baseline Brand NameVNS THERAPY LEAD
Baseline Generic NameBIPOLAR LEAD
Baseline Catalogue NumberNA
Baseline Model Number302-20
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)36
Date First Marketed06/20/2002
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd.
ste. 600
houston TX 77058
Manufacturer Contact
darlene garner, rac
100 cyberonics blvd.
ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key457465
MDR Report Key468565
Event Key444079
Report Number1644487-2003-00365
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/04/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date01/31/2005
Device MODEL Number302-20
Device LOT Number7596
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/04/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2003
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/30/2003 Patient Sequence Number: 1
#TreatmentTreatment Date
1,MODEL 102 VNS THERAPY PULSE, EXPIR DATE
2,11/30/2004, DATE OF MFG 12/16/2002, STERILIZATION
3,LOT NO. 7519.
 
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